A Comparison Between the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training Early After Stroke

Study Overview
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Brief Summary
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Overall aim is to evaluate HAL for gait training early after stroke and the effect of HAL on short- and long-term functioning, disability and health compared to conventional gait training as part of an inpatient rehabilitation program early after stroke.

Detailed Description
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To compare outcome after 4 weeks of gait training with HAL vs. 4 weeks of conventional gait training as part of a regular inpatient rehabilitation program for hemiparetic patients with severely limited mobility early after stroke. Study design: Randomized, controlled study with blinded outcome assessment. Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups. Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.

Official Title
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Gait Training Early After Stroke - a Comparison Between Training With the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training

Conditions
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Stroke, Gait, Hemiplegic, Ambulation Difficulty, Hemiparesis

Intervention / Treatment
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* Device: Hybrid Assistive Limb (HAL); gait training
* Other: Control Group; Conventional gait training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: less than 8 weeks since stroke onset; inability to walk independently due to lower extremity paresis (i.e. FAC score 0-1), able to sit on a bench with or-without supervision at least five minutes; sufficient postural control to allow upright position in standing with aids and/or manual support; ability to understand training instructions as well as written and oral study information and to express informed consent; body size compatible with the HAL suit. Exclusion Criteria: contracture restricting gait movements at any lower limb joint; cardiovascular or other somatic condition incompatible with intensive gait training; and severe, contagious infections.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 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: Study Group<br>Intervention: Hybrid Assistive Limb (HAL); gait training in combination with conventional training. Training with the exosceleton Hybrid Assistive Limb (HAL) is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method. | Device: Hybrid Assistive Limb (HAL); gait training<br>* Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.<br>* Other names: Hybrid Assistive Limb (HAL);|
| Active Comparator: Control Group<br>Intervention: Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups. | Other: Control Group; Conventional gait training<br>* Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Ambulation Categories (FAC) | Level of independence in walking, range 0-5 | Assessed at baseline, after 4 weeks of training and 6 months after stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotics, Rehabilitation