Treadmill Therapy and Brain Injuries

Study Overview
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Brief Summary
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Introduction. There is a demand for evidence whether treadmill therapy is more efficient than traditional walking training as an intervention for patients with hemiplegia after cerebral stroke. Design. A randomized controlled trial. Material. Stroke patients with moderate to severe functional deficits referred to inpatient medical rehabilitation. Method. Comparing a treatment group receiving treadmill training with body weight support with a treatment group receiving conventional walking training. Study aim: Investigate whether treadmill therapy is more effective than traditional functional training in restoring walking and transfer in patients with moderate to severe ambulatory deficits after stroke.

Detailed Description
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See Brief Summary.

Official Title
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The Effect of Treadmill Therapy With Body Weight Support on Walking and Transfer in Patients With Moderate to Severe Ambulatory Deficits After Stroke

Conditions
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Cerebral Stroke, Hemiplegia, Moderate to Severe Functional Impairments

Intervention / Treatment
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* Other: Treadmill therapy and conventional walking therapy.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cerebral stoke Hemiplegia Primary rehabilitation Medical stable Wheelchair user Dependent of assistance for walking Dependent of maximum one person for transfer No physical impairments that could prevent walking ability from being restored Able to participate in the training modalities Exclusion Criteria: Medical unstable Orthopaedic or other impairments preventing relearning walking Cognitive impairments that prevents understanding the study information Cognitive or psychological impairments that prevents study collaboration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill therapy<br>Patients assigned to the Treadmill therapy group received daily 30 minutes specific walking training on treadmill with body weight support alternatively overground, and 30 minutes functional training, treated by a physiotherapist. | Other: Treadmill therapy and conventional walking therapy.<br>* The experimental group received 30 sessions of treadmill therapy with body weight support for a time period of 10 weeks. The conventional group received traditional walking therapy for the same time period.<br>* Other names: Traditional walking therapy;|
| Active Comparator: Conventional walking therapy<br>Patients assigned to the comparative conventional walking therapy group received daily 30 minutes specific traditional walking training overground and 30 minutes functional training, treated by a physiotherapist. | Other: Treadmill therapy and conventional walking therapy.<br>* The experimental group received 30 sessions of treadmill therapy with body weight support for a time period of 10 weeks. The conventional group received traditional walking therapy for the same time period.<br>* Other names: Traditional walking therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ambulation Categories. Ten meter walking test. Six minutes walking test. Functional Independence Measure (task 9 shorter transfer and task 13 stairs). |  | 0, 5 weeks and 10 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EU-Walking Index. Time of Shorter transfer. Time of Climbing stairs. Performance of climbing stairs. Heart rate registration. * Temporospatial 3D gait data (a sub group analysis). ** Semistructured interview. |  | 0, 5 and 10 weeks, * 0 and 10 weeks, **10 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Injury, Rehabilitation, Treadmill therapy