Effects of Paretic Lower Limb Loading During Overground Training
Study Details
Study Description
Brief Summary
The ability to walk properly after stroke is a highly desired goal among stroke survivors and their relatives; because the gait is believed as a yardstick for measuring recovery, too much time is spent on gait re-education and recovery of mobility during rehabilitation. Despite rehabilitation efforts, almost 80% of survivors still experience impaired walking function and a further 22% do not regain any walking function at all.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Stroke is the second leading cause of death in both developed and developing countries. Stroke as one of the major public health problems in the world is also one of the most common causes of long-term disabilities among adults.
A study has revealed that the use of additional weight on the affected lower limb in aquatic exercise medium improves stability in the stance phase and decreased unwanted limb flotation in people with stroke. However, the study was limited by the use of handrail which could affect the study outcomes due to restriction of trunk and arm movements. Also, the outcome of the study is not generalizable because water qualities such as buoyancy may have had an influence on some gait outcomes. As such, the findings may not be the same as what can be obtained with over-ground training. It is observed however that little attention has been given to applying weight on the paretic lower limb during over-ground training as a means of correcting Spatio-temporal gait asymmetry and improving lower limb motor functions in the clinics and there is a paucity of research in that area. Only a cross-sectional study reported that a single bout of weight application at the knee and ankle were both found to influence changes in the Spatio-temporal parameters and gait symmetry with ankle loading leading to changes in more gait parameters. It is apparent that there is a need for well-designed research to evaluate the influence of paretic limb loading during over-ground training on Spatio-temporal gait parameters and lower extremity recovery post-stroke. Furthermore, paretic limb loading during the over-ground approach could also be more accessible and affordable in a resource constraint setting compared to the aquatic and treadmill training. This study is hoped to serve as an RCT to evaluate the effects of paretic lower limb loading during over-ground training on gait characteristics (Spatio-temporal gait parameters, gait symmetry) and motor functions among stroke survivors.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group i - Warm-up (5 minutes) ii- Conventional physiotherapy exercise (15 minutes) iii - Over-ground training with lower limb loading (15-25 minutes) |
Behavioral: Warm-up (5 minutes)
Participants will benefit from passive stretches of hamstrings, calf muscles including a range of motion (ROM) exercise to the lower limbs as mat exercises.
Behavioral: Conventional physiotherapy exercise (15 minutes)
The conventional treatments will be active-assisted and free active exercises to the lower limbs on the mat for five (5) minutes. This will be followed by strength training such as sit-to-stand exercises for five (5) minutes and squatting exercises for five (5) minutes prior to the over-ground training.
Behavioral: Over-ground training with lower limb loading (15-25 minutes)
Participants will perform the over-ground training exercise with an external 1.5kg load on the paretic lower limb placed 2cm above the ankle joint. Before commencing the over-ground training, all the participants will observe a pre-exercise rest period of about two (2) minutes during which their heart rate and blood pressure measurements will be recorded.
The over-ground training will involve the patients walking within a demarcated path. Each participant will be instructed to stand and walk 15meters to and fro for five (5) minutes after which they will be asked to stop and rest for two (2) minutes. The over ground training exercise will be repeated 3 times in the first 2 weeks of the training (15 minutes); 4 times in weeks 3-4 of the training (20 minutes); and 5 times in weeks 5-8 of the training (25 minutes).
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| Active Comparator: Control group i - Warm-up (5 minutes) ii- Conventional physiotherapy exercise (15 minutes) iii - Over-ground training WITHOUT lower limb loading (15-25 minutes) |
Behavioral: Warm-up (5 minutes)
Participants will benefit from passive stretches of hamstrings, calf muscles including a range of motion (ROM) exercise to the lower limbs as mat exercises.
Behavioral: Conventional physiotherapy exercise (15 minutes)
The conventional treatments will be active-assisted and free active exercises to the lower limbs on the mat for five (5) minutes. This will be followed by strength training such as sit-to-stand exercises for five (5) minutes and squatting exercises for five (5) minutes prior to the over-ground training.
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Outcome Measures
Primary Outcome Measures
- Spatial gait parameters and symmetry [Change from baseline spatial gait parameters at 4 weeks; Change from baseline spatial gait parameters at 8 weeks]
Each participant will perform three trials of walking and the spatial gait parameters will be recorded in each trial; the average will be computed. The measurements will be carried out in centimeters (cm) using measuring tape each for the paretic lower limb loading and paretic lower limb non-loading during the over-ground training. The parameters to be measured are: Step length, stride length, foot angle, and stride width.
- Temporal gait parameters and symmetry [Change from baseline temporal gait parameters at 4 weeks; Change from baseline temporal gait parameters at 8 weeks]
Each participant will perform three trials of walking and the temporal gait parameters will be recorded in each trial; the average will be computed. The measurements will be carried out in seconds (sec) using a stop watch each for the paretic lower limb loading and paretic lower limb non-loading during the over-ground training. The parameters to be measured are: Step time, stride time, single limb support time, stance time, swing time, cadence, and gait speed.
- The Lower limb motor functions [Change from baseline lower limb motor function at 4 weeks; Change from baseline lower limb motor function at 8 weeks]
The Motricity Index will be used to measure the lower limb functions of the participants. It is a reliable instrument for measuring the strength of the involved lower extremity when assessment following chronic stroke. Participant position: The test is administered in a sitting position. Patient will be asked to sit on a chair or on the edge of the bed. In the lower limb, the three movements to be tested are: hip flexion, knee extension, and dorsiflexion. The assessment will be carried out just before the over-ground training. All the data will be recorded. Thereafter, the total score of each participant will then be computed and documented. Scorings: 0 (No movement); 9 (Palpable contraction in muscle, but no movement); 14 (Visible movement, but not full range and not against gravity); 19 (Full range movement against gravity, but not resistance); 25 (Full movement against gravity, but weaker than the other side); 33 (Normal power).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Unilateral ischemic or hemorrhagic stroke occurring at least 3 months before enrolment
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Male or female between the age of 20 and 70 years
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Having a Modified Rankin Scale (MRS) scores of 1, 2, or 3, and also able to walk at least 10 meters independently without an assistive device
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Ability to follow verbal instructions.
Exclusion Criteria:
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Cognitive impairments
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Visual impairments
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Musculoskeletal disorders that may affect gait such as arthritis
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Other neurological disorders such as Parkinson's disease, multiple sclerosis
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Cardio-respiratory conditions that may limit participation such as atelectasis
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Concurrent participation in other interventional clinical trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Muhammadu Abdullahi Wase Teaching Hospital | Kano | Nigeria | 700282 |
Sponsors and Collaborators
- Bayero University Kano, Nigeria
Investigators
- Principal Investigator: Abdulhamid U Maje, M.Sc., Muhammadu Abdullahi Wase Teaching Hospital, Kano State
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPS/18/MPT/00033