Effects of a Lower Limb Strength Training Program on a Seated Robotic Device in Patients

Study Overview
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Brief Summary
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The loss of lower limb strength that occurs after an Acquired Brain Injury (ABI) limits the patient's autonomy in participating in activities of daily living, including gait performance. In the sub-acute phase, it is difficult to implement a strengthening program, as weakness prevents exercise being performed with the recommended parameters. This limit can be exceeded by using specific robotic devices, which allow the effort provided to be adapted according to the patient's capacities. In addition, motivation can be improved by the use of feedback or incentive games. The aim of this pilot study is to obtain data on the effect of lower limb strength training with a seated robotic device in subacute ABI patients for a future larger randomised study. In addition, it aims to evaluate the recruitment rate, applicability, resources for implementation and patient tolerance to the training program.

Official Title
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Effects of a Lower Limb Strength Training Program on a Seated Robotic Device in Subacute Acquired Brain Injury Patients: a Pilot Study.

Conditions
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Stroke

Intervention / Treatment
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* Device: Group of strength training
* Other: Group of physiotherapy not focus on strength training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acquired Brain Injury of vascular, traumatic, infectious or tumoral origin in the subacute phase Walking ability ≤ Functional Ambulatory Category level 4 (1-6) Paresis of the lower limb: strength <57/100 on the Motricity Index Cognitive and memory functions allowing the patient to follow treatment instructions and give informed consent Exclusion Criteria: Significant heart problem Venous thrombosis less than 6 months Musculoskeletal impairment not compatible with movement Degenerative neurological disease Oxygen-dependent Blood pressure not stabilized

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>group focus on lower limb strength training with a seated robotic device | Device: Group of strength training<br>* 2x a week during 5 weeks, strengthening of weak muscles with the intensity recommended in the literature, i.e. 3-4x15 repetition at an intensity of 50 to 80% of the maximum force combined with serious games to stimulate patient involvement in strength training<br>|
| Active Comparator: control group<br>physiotherapy group as usual, not focused on strength training | Other: Group of physiotherapy not focus on strength training<br>* 2x a week during 5 weeks, active physical therapy treatment based on movement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from study inclusion to end of intervention at 5 weeks in strength of knee extensor's | measure with a manuel dynamometer, in newton | Study inclusion to end of intervention at 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from study inclusion to end of intervention at 5 weeks in Motricity index legs | clinical manuel strength test, seating on a chair. From 0 to 33, 33 is normal strength. | Study inclusion to end of intervention at 5 weeks | 
| change from study inclusion to end of intervention at 5 weeks in timed up and go | Mobility test: standing from a chair, walking 3 meters, turn around, returning and seat. in seconds | Study inclusion to end of intervention at 5 weeks | 
| change from study inclusion to end of intervention at 5 weeks in 10 meters walk test | measure of mean gait speed on 10 meters, at comfortable and maximum gait speed. In meters/second. | Study inclusion to end of intervention at 5 weeks | 
| change from study inclusion to end of intervention at 5 weeks in Ashworth Scale (spasticity) | measure of the resistance of a muscle to passive stretch according to REsistance to PASsive movement protocol. From 0 to 4, 4 is high spasticity. | Study inclusion to end of intervention at 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lower limb, robotic device, strength training, subacute, rehabilitation