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Many studies have examined specific therapeutic approaches to improve functioning of the lower extremity. A Cochrane review by Pollock et al. (2007) examined the efficacy of various treatment approaches for lower limb rehabilitation. The results from 21 RCTS were included; eight trials examined neurophysiological approaches, eight examined motor learning approaches, and eight examined mixed approach. The authors reported that a mixed approach was significantly more effective than no treatment or placebo control for improving functional independence (standardized mean difference=0.94, 95% CI 0.08-1.80). Nevertheless, the authors concluded that there was insufficient evidence that any single approach had a better outcome than any other single approach or no treatment control.
Task Oriented Training (Task-Specific Training)
Task oriented training (also called task-specific training) involves practicing real-life tasks, with the intention of acquiring or reacquiring a skill. The tasks should be challenging and progressively adapted and should involve active participation. Evidence suggests that this type of therapy helps to improve gait speed and endurance. A Cochrane review by English and Hillier (2010) pooled findings from six RCTs that examined repetitive practice of functional tasks arranged in a circuit with the aim of improving mobility. Compared with the control condition, there were significant improvements in performance on the 6-Meter Walk Test (6MWT; MD=76.6 m, 95% CI 38.4 to 114.7, p<0.0001) and gait speed (MD=0.12, 95% CI 0.0 to 0.24, p=0.043), but not on measures of balance or on Timed Up and Go (TUG). More recently, Van de Port et al. (2012) recruited 250 stroke in-patients who were able to walk 10 m without physical assistance and were randomized to receive a graded task specific circuit training program or usual outpatient physiotherapy. After 24 weeks, patients in the task-specific therapy group had significantly higher scores on the mobility sub-scale of the Stroke Impact Scale (SIS) and increased distance walked on the 6MWT, compared with patients in the control group. Salbach et al. (2004, 2005) randomized 91 community-dwelling participants with a residual walking deficit within one year of stroke to an intervention group which comprised 10 functional tasks designed to strengthen the lower extremities and enhance walking balance, speed and distance or to a control intervention focusing on upper extremity activities. Patients in the active intervention group walked a further distance on the 6MWT and increased their comfortable and maximal walking speed to a greater degree compared with patients in the control group.
Treadmill Training without Body Weight Support
Treadmill training can also be used to increase walking speed, endurance and distance late post stroke. Macko et al. (2005) reported that 61 chronic stroke patients with hemiparetic gait patients who received 6 months of progressive treadmill aerobic exercise program had significantly greater improvement in ambulatory performance and mobility function compared with patients in a control group who received a program of stretching plus low-intensity walking. Langhammer and Stanghelle (2010) reported that patients in the treadmill group had better walking speed, endurance, and walking distance following an intervention consisting of 30 minute treadmill training sessions, five days per week for 2.5 weeks versus a control intervention consisting of outdoor walking. Nadeau et al. (2013) conducted an RCT in which participants received one of three treatment options: 1) a locomotor training program (LTP) consisting of treadmill training with over ground training; 2) a home exercise program (HEP) with a focus on balance, strengthening, and coordination; or 3) usual care. Treatment consisted of a total of 30-36 sessions, 3 times per week, each lasting 90 minutes. Improvements in walking speed, the Fugl-Meyer, Berg Balance Scale (BBS), and the modified Rankin Scale were demonstrated by all groups. Greater improvements were demonstrated by both the LTP and HEP groups compared to the usual care group on the BBS and physical mobility.
Treadmill Training with Body Weight Support (BWSTT)
Treadmill training with body weight support may also be effective for patients with initial poor ambulatory status, although the evidence is less clear. Duncan et al. (2011) randomized 408 community-dwelling patients with stroke onset of 2 months, who were able to walk 3 metres with maximum of one person assist, to receive a 3-4 month course of early or delayed treadmill training with partial body-weight support or to a home-based exercise program. At one-year, 52% of all patients had improved functional walking ability. There was no difference in the proportion of improvement found among the 3 groups. In the MOBILISE trial, (Ada et al. 2010, Dean et al. 2010) 126 patients within 28 days of stroke were randomized to an experimental or a control group and received treatment until they achieved independent walking or for as long as they remained in hospital. Participants in both groups received 30 minutes of walking practice 5 days/week. Additional lower-limb therapy was provided for an additional 30 minutes/day. Participants in the experimental group undertook up to 30 minutes per day of treadmill walking with sufficient body weight support such that initially, the knee was within 15 degrees of extension in mid stance. The control group received up to 30 minutes of over-ground walking training, with the use of aids, if required. Although there were no differences in the proportion of independent ambulators between groups at one, two or 6 months, participants in the experimental group achieved independence in ambulation a median of 14 days sooner. Kelley et al. (2013) randomized individuals to receive either robotic-assisted body weight supported treadmill training on the Lokomat or traditional over-ground gait training. Treatment sessions were 1 hour in length, 5 days a week, for 8 weeks. No significant differences were identified between groups at post intervention, or at the 3 month follow-up. In a study comparing treadmill training based real-world video recording (TRWVR) to normal treadmill walking, with all participants still receiving standard therapy, Cho and Lee (2014) found significant improvements by both groups on the BBS, TUG test, gait speed, cadence, single limb support period, double limb support period, step length and stride length. On these same measures the TRWVR group improved significantly more than the control group. Furthermore, Riberio et al. (2013) evaluated the effects of treadmill training with partial body-weight support (TPBWS) to proprioceptive neuromuscular facilitation (PNF). Following training, both groups improved significantly on the Stroke Rehabilitation Assessment of Movement (STREAM), Functional Independence Measure (FIM®), and symmetry ratio. Maximum ankle dorsiflexion over the swing phase was significantly greater than the TPBWS group. Lee et al. (2013) compared body weight support treadmill training with power assisted FES to BWSTT alone. It was found that both groups improved significantly on the BBS, TUG, STREAM, velocity, cadence, paretic side step length and stride length, with the BWSTT with FES group improving more on every measure. Bonnyaud (2014) conducted a similar study in which participants received experimental Lokomat training with a negative kinematic constraint on the non-paretic limb and a positive kinematic constraint on the paretic limb, or conventional Lokomat training. No statistically significant between-group differences were noted on any of the measures such as gait velocity, step length, and cadence. In addition, Ada et al. (2013) compared three different treatments: 1) treadmill and over ground walking for 30 minutes, 3 times per week, for either 2 or 4 months; or 2) no intervention. The authors found that there were no between-group differences on walking speed, the EuroQoL, the Adelaide Activities Profile, or the Walking Self-Efficacy Scale. The 4-month training group walked further than the control group at 2 and 4 months, but not at 12 months; furthermore, the 2-month training group walked further than the control at 2 months but not at 4 months.
Aerobic training can be used to improve measures of gait performance. A Cochrane review (Brazzelli et al. 2011) included the results from 32 trials of patients in both the acute and chronic stages of stroke. Interventions were classified as 1) Cardiorespiratory training versus usual care, 2) Resistance training versus usual care and 3) Mixed training interventions, which included combinations of cardiorespiratory and resistance training methods. At the end of follow-up, cardiorespiratory training was not associated with reductions in disability (measured by FIM), but maximal and preferred walking speed and walking capacity were significantly improved. Increased gait speed and improved walking capacity were also associated with mixed training interventions. Pang et al. (2006) also conducted a systematic review of aerobic exercise following stroke, which included the results from 7 RCTs, evaluating patients in all stages of stroke recovery. Exercise intensity in the included studies ranged from 50% to 80% of heart rate reserve, while duration varied from 20-40 min for 3-5 days a week for 3-19 weeks. Regardless of the stage of stroke recovery, there was a significant benefit of therapy. Improvements were noted in the parameters of peak VO2, peak workload, walking speed and endurance. Jin et al (2012) and Globas et al. (2012) reported significant improvements in measures of cardiovascular fitness, walking ability and performance in patients more than 6 months post stroke who had received a progressive graded, high-intensity aerobic treadmill exercise or aerobic cycling exercise, with lower extremity weights. MacKay-Lyons et al. (2013) reported that a 12-week aerobic conditioning program using body-weight supported treadmill training was associated with improvements in cardiovascular fitness and walking ability that were sustained for one year. According to the Aerobic Exercise Recommendations to Optimize Best Practices in Care After Stroke (AEROBICS) 2013 guidelines, there is a strong recommendation for the inclusion of aerobic training into stroke rehabilitation, as well as the use of task-specific exercises that engage large muscle groups. The panel also strongly recommends a minimum of 8 weeks of aerobic exercise to ensure clinically meaningful training effect, but they also recommend aerobic exercise indefinitely in order to maintain the health benefits. Moreover, the guidelines strongly recommend physical activity for a minimum of 3 days per week, but they suggest most days of the week. A strong recommendation is also made for exercise session to last a minimum of 20 minutes with a cool-down portion lasting between 3 and 5 minutes. Finally, to ensure safe aerobic exercise, there is a strong recommendation to adjust the intensity of aerobic activity based on individual parameters (e.g., stress test, health status, etc.).
Electromechanical/Robot-Assisted Gait Training Devices
In an updated Cochrane review (Mehrholz et al. 2014), 23 studies (999 subjects) were examined to determine the effectiveness of electromechanical and robot-assisted gait training for improving walking after stroke. Treatments included electromechanical and robot-assisted gait training devices (with or without electrical stimulation) which are designed to assist stepping cycles by supporting body weight and automating the walking therapy process with the addition of physiotherapy compared with physiotherapy or routine care only. Treatment was not associated with increases in gait speed. The odds of becoming an independent ambulator was significantly increased for all patients (OR 2.39, 95% CI 1.67-3.43; p’0.00001), but particularly more so for those who had experienced their stroke <3 months previously (OR=2.75, 95% CI 1.86 to 4.08, p<0.00001). Morone et al. (2011, 2012) included 48 participants, an average of 20 days post stroke, stratified by motor impairment (high vs. low). All patients underwent standardized rehabilitation for 3 months. After one week of therapy, participants in the robotic group underwent additional robotic-assisted gait training instead of a second therapy session (20 sessions in total). Participants in the control group participated in a second therapy session. At the end of treatment participants in the low impairment robot group had improved significantly more than participants in the low impairment control group on the Functional Ambulation Category (FAC) (p<0.001), the Rivermead Mobility Index (p=0.001) and the 6-Minute Walk test (p=0.029). Although participants in the high impairment groups also improved over time, there were no significant between-group differences on any of the outcomes. At 2 year follow-up, patients in the low impairment robot group continued to demonstrate significantly improved scores, while there were no significant differences between groups for highly-impairment patients. In a recent RCT by Dragin et al. (2014), the use of the Walkaround was compared to conventional training. Sessions lasted 30 minutes per day, 5 days per week, over a period of 4 weeks. After treatment concluded, the experimental group improved significantly greater than the control group in terms of gait speed and Berg Balance Scale score, these differences were also demonstrated at 6 months post treatment.
In a recent RCT by Mohan et al. (2013), participants engaged in either mirror therapy with conventional therapy, or conventional rehabilitation alone. Both groups improved significantly on the FMA-LE, and Brunnel Balance Assessment; however, there were no between-group differences. On the Functional Ambulation Categories, the mirror therapy group improved significantly, while the conventional treatment did not.
Strength training is an essential component of lower limb rehabilitation following stroke. Flansbjer et al. conducted an RCT (2008) and a 4 year follow-up (2012) study comparing chronic stroke patients who underwent supervised progressive resistance training of the knee extensors and flexors (80% of maximum; 2 times per week for 10 weeks) to those who continued their usual daily activities. The authors found that muscle strength in the intervention group improved significantly compared to the control group and these results were maintained at the 4 year follow-up. There was no reduction in strength in the control group; however, between-group differences were still significant for both isotonic and isokinetic strength. Following the intervention there was an increase in gait performance for both groups; however, at the 5 month follow-up in the first study only the TUG and perceived participation were significantly better among the training group participants. There were no significant between-group differences in muscle tone, gait performance, or perceived participation at the four year follow-up. Furthermore, in an RCT by Cooke et al. (2010), participants with subacute stroke (mean 1 month) were randomized to one of three treatment groups for 6 weeks: 1) conventional physiotherapy (CPT) + Functional Strength training (FST); 2) extra intensity training (CPT + CPT); or 3) CPT alone. At post intervention both experimental groups showed improvement in walking speeds over the CPT alone group, but this reached significance in the CPT + CPT group. The CPT + CPT group also showed significant improvement in the number of participants with a walking speed over 0.8m/s compared to the CPT group. No significant differences were noted between-groups for torque about the knee, symmetry step length, symmetry step time, the Rivermead score, or on the EuroQoL. At the 12 week follow-up no significant differences were identified between groups.
An RCT by McEwan et al. (2014) compared the effectiveness of a virtual reality exercise program for balance (that challenged balance) plus standard rehabilitation to a VR program (that did not challenge balance) plus standard rehabilitation. The experimental group improved significantly more than the control group on the Chedoke McMaster Stroke Scale leg domain post treatment and at 1 month follow-up. The two groups did not differ significantly on the TUG or TMWT.
Ankle-Foot Orthoses (AFO)
The use of ankle-foot orthoses is widespread, although there are few controlled trials examining its benefit. When patients who had been wearing an AFO regularly for the previous 6 months were assessed with and without the orthosis, measures of gait speed were significantly better when the AFO was worn (de Wit et al. 2004). Similarly, when 58 patients who had never worn the device previously were assessed with, and without an AFO two hours apart, measures of balance and gait speed were significantly better when the AFO was worn (Wang et al. 2007). In 32 chronic stroke survivors who were randomized to wear or not wear an AFO for a period of three months, gait speed was significantly increased as was and Physiological Cost Index (beats/min) in patients who had worn the device. Tyson and Kent (2013) recently conducted a systematic review, including the results from 13 crossover RCTs. During a single testing session, participants performed significantly better on measures on balance (weight distribution: SMD=0.32, 95% CI -0.52 to -0.11, p=0.003) and mobility (gait speed: MD=0.06 m/s, 95% CI, 0.03 to 0.08, p<0.0001 and stride length: SMD= 0.28, 95% CI 0.05 to 0.51, p=0.02) while wearing an AFO compared with control condition where an AFO was not worn. There were no significant treatment effects associated with the outcomes of postural sway and timed mobility tests. In another RCT, Clark and Patten (2013) evaluated chronic stroke participants who received either concentric resistance training (CON) or eccentric resistance training (ECC); both groups also received gait training. Both groups improved significantly on self-selected walking speeds, and fast walking speed; however, no significant between-group differences were noted for either measure.
Functional Electrical Stimulation (FES)
Functional electrical stimulation (FES) can be used to improve gait quality in selected patients who are highly motivated and able to walk independently or with minimal assistance. FES has been studied extensively with RCTs; however, the results of a Cochrane review (Pomeroy et al. 2006) including the results from 24 RCTs, of which 12 included interventions and outcomes associated with mobility, suggest that treatment is not associated with significant increases in gait speed (SMD= -0.02, 95% CI -0.30 to 0.26) or stride length (SMD=0.36, 95% CI -0.93 to 1.63). Ambrosini et al. (2011) did report significant improvement in Motricity Index scores (leg subscale) and the Trunk Control Test in 35 lower-functioning patients randomized to receive FES-induced cycling training using a motorized cycle-ergometer. Tan et al. (2014) performed a RCT evaluating 45 participants who sustained a first time ischemic stroke (within 3 months of onset) and received FES or placebo. A significant difference in Fugl Meyer Assessment – Lower extremity motor (FMA-LE) scores after treatment was found between the four channel and dual-channel groups (p= 0.024), but not between the four-channel and placebo groups (p=0.062). After treatment a significant difference between the four-channel and placebo groups was found in the PASS (p= 0.031) and Berg Balance Scale (BBS) (p= 0.022). On the Modified Barthel Index (MBI), the four-channel group had significantly greater improvement compared to the placebo (p= 0.039) and dual channel groups (p= 0.021). Significant differences were found only between the four-channel and placebo groups on the BBS (p= 0.028), and MBI (p= 0.047) at the 3 month follow up. In study examining 18 participants with stroke and receiving FES or sham, Chung et al. (2014) reported that participants had a manual muscle test grade below 2 and ability to walk 10m without assistance. The experimental group showed a significant improvement in gait velocity (p=0.010), cadence (p=0.040), stride length of the affected side (p=0.015), and stride length of the less affected side (p=0.030). No significant improvements were shown in the control group. Therefore, greater improvements were shown for the experimental versus control group (p<0.05). Greater improvements were shown through the mean BBS scores for the experimental versus control group (p<0.001). Spaich et al. (2014) conducted an RCT evaluating 30 individuals within 9 weeks from post stroke. Participants were capable of walking a maximum of 10 metres without help from therapists. Participants all received intensive physiotherapy-based gait training; however, the treatment group had gait training in combination with activation of the nociceptive withdrawal reflex by FES (NWR-FES). Preferred walking velocity and maximum walking velocity was significantly faster for the NWR-FES group post-treatment (p<0.001). Those with severe walking impairment at inclusion in the treatment group showed the best improvement on duration of stance on paretic side (p<0.002), and a shorter duration of gait cycle (p<0.002). Stance symmetry ratio was also significantly better for the treatment group after training (p<0.02).
Neuromuscular Electrical Stimulation (NMES)
Neuromuscular stimulation is another form of stimulation that has been used for improving functionality in a variety of populations. An RCT by Knutson et al. (2013) involving 24 stroke patients (onset ≥6 months) with foot drop during ambulation and less than normal ankle dorsiflexion strength (Medical Research Council Scale score of ≤4/5) were enrolled. Patients were randomized into 6 weeks of treatment in either the contralaterally controlled neuromuscular electrical stimulation (CCNMES) group (n=12) or the cyclic neuromuscular electrical stimulation (NMES) group (n=12). The assigned stimulator was used at home and both groups also received conventional post-stroke gait training from a physiotherapist in lab sessions. The primary outcome was FMA-LE; there were no significant differences between groups in the outcome trajectories for any of the measures. When the data after treatment from both groups was pooled, there were significant changes shown for the modified Emory Functional Ambulation Profile (p=0.01) and the FMA-LE (p<0.01).
Foot Drop Stimulators
Foot drop stimulators have been used to improve foot drop post stroke. Kluding et al. (2013) reported results from a randomized cross-over study of 197 participants who sustained a stroke ≥3 months before intervention and had a gait speed of ≤0.8m/s. Patients were randomized into either the foot drop simulator (FDS) or the standard AFO group. Both groups received physical therapy treatment as well. At 30 weeks, the AFO group switched to FDS and continued for 12 weeks, whereas the FDS group continued with the same treatment. At 30 weeks, significant improvements were identified in both groups for comfortable and fast gait speed (p<0.001). However, between groups, immediate device effects were shown for fast gait speed (p=0.018) and BBS (p=0.039) and for long-term effect on the BBS (p=0.022). User Satisfaction was significantly higher in the FDS group compared to the standard treatment with the AFO (p<0.001). Sheffler et al. (2013) conducted a RCT including 110 individuals with hemiparetic stroke (≥12 weeks post stroke). Participants could ambulate ≥30 ft. without an AFO and ≥24 on the BBS. Participants were placed in either an ambulation training group with peroneal nerve stimulator (PNS – Odstock Dropped-Foot Stimulator), or usual care group (AFO or no device). The primary outcome was FMA-LE. There was no significant treatment group main effect on the FMA-LE (p=0.797), the mEFAP (p=0.968), or the SSQOL scale (p=0.360). Another study examined the use of Walkaide and Ankle Foot Orthosis (AFO) (Everaert et al. 2013). The participants were randomized into three groups: 1) WalkAide then AFO; 2) AFO then WalkAide; or 3) AFO for both phases. Each phase lasted 6 weeks. All groups significantly improved on the Figure-8 task, the 10m walk, and the modified Rivermead Mobility Index. Walking performance, as measured by the Figure-8 and 10m walk were not significantly different between the WalkAide and AFO after the first or second phase. Greater orthotic effect was shown at phase 1 and 2 for the AFO compared to the WalkAide.