Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact of an isokinetic strength training of knee flexor and extensor muscles on walking performance in hemiparetic patients with knee extension thrust.

Detailed Description
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The study will be interventional single case experimental design (SCED) with multiple baseline design. SCED are experimental designs aiming at testing the effect of an intervention using a small number of patients using repeated measurements, sequential and randomized introduction of an intervention and method-specific data analysis, including visual analysis and specific statistics. During baseline, patients will have a rehabilitation program in day hospital (4 days per week) with physiotherapy and physical activity and if necessary occupational and speech therapy. Isokinetic strength training will be added to this conventionnal rehabilitation program and will begin after 3, 4 or 5 weeks of baseline according to randomization 12 patients will be included in this study (6 patients in subacute stage and 6 in chronic stage ).

Official Title
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Effects of Isokinetic Strength Training of Knee Flexor and Extensor Muscles on Walking in Hemiparetic Patients With Knee Extension Thrust

Conditions
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Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), Gait Disorder

Intervention / Treatment
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* Behavioral: isokinetic strength training of knee extensor and flexor muscles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemiparetic patient (hemorragic or ischemic stroke) Subacute stage (< 6 Months) ou chronic stage of stroke (> 6 months) (6 patients in each group) Age between 18 and 75 years Able to walk 10 meters independently without any assistive devices Knee extension thrust during stance phase of gait cycle (rapid posterior movement of the knee toward extension) Scheduled rehabilitation program with isokinetic strength training affiliation to a social security Patients who received and signed informed consent Exclusion Criteria: Major comprehension deficit that not allow to give informed consent and participate to isokinetic strength training (assessed with comprehension subscore of Langague screening Test) non stable (unstable cardiovascular condition) musculoskeletal disorders with knee pain that not allowed isokinetic strength training Botulinum toxin injection less than 3 months or repeated injection in lower limb, Proprioception trouble assessed with proprioception section of the Fugl-Meyer Assessment [FMA-P] 0/2 spasticity of triceps surae ≥2 (Modified Ashworth scale) ankle dorsiflexion angle less than 90° pregnant women or breastfeeding persons with safety measure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Factorial Assignment
Interventional Model Description: Single Case Experimental Design (SCED)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 assessments<br>The randomisation provides for 3 assessments of baseline | Behavioral: isokinetic strength training of knee extensor and flexor muscles<br>* Patients underwent an isokinetic strength training program with 3 sessions per week during five weeks. Program consists of excentric contraction of knee flexor and extensor muscles (4 x 7 Contractions at 30°/s) and concentric contractions at maximal speed where patients can perform 40% of his maximal isometric torque for knee flexor and extensor muscles (2x10 for knee flexors and 2x10 for knee extensors)<br>|
| Experimental: 4 assessments<br>The randomisation provides for 4 assessments of baseline | Behavioral: isokinetic strength training of knee extensor and flexor muscles<br>* Patients underwent an isokinetic strength training program with 3 sessions per week during five weeks. Program consists of excentric contraction of knee flexor and extensor muscles (4 x 7 Contractions at 30°/s) and concentric contractions at maximal speed where patients can perform 40% of his maximal isometric torque for knee flexor and extensor muscles (2x10 for knee flexors and 2x10 for knee extensors)<br>|
| Experimental: 5 assessments<br>The randomisation provides for 5 assessments of baseline | Behavioral: isokinetic strength training of knee extensor and flexor muscles<br>* Patients underwent an isokinetic strength training program with 3 sessions per week during five weeks. Program consists of excentric contraction of knee flexor and extensor muscles (4 x 7 Contractions at 30°/s) and concentric contractions at maximal speed where patients can perform 40% of his maximal isometric torque for knee flexor and extensor muscles (2x10 for knee flexors and 2x10 for knee extensors)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spontaneous walking speed | Spontaneous walking speed of hemiparetic patients recorded with 3D gait analysis | 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extensor thrust analysis | Extensor thrust at spontaneous and maximal walking speed and during dual task recorded with 3D gait analysis | 25 weeks | 
| Walking speed | assessment of walking speed in two conditions (maximal speed and dual task) | 25 weeks | 
| Stairs test | time to ascend and descend stairs (maximal speed) | 25 weeks | 
| Inclined plan | time to walk in an inclined plan (maximal speed) | 25 weeks | 
| 6-minute walk test | Assessment of maximum gait perimeter during a 6MWT (6-minute walk test :6MWT) | 25 weeks | 
| Sit to stand test | 1 minute sit to stand test (number of repetitions) | 25 weeks | 
| Extensor thrust during locomotor tasks | Extensor thrust analysis with inertial measurement unit (stairs, inclined walk, 6MWT and sit to stand ) | 25 weeks | 
| Fatigue | Fatigue severity scale : FSS (minimum 9 -maximum 63 ; a higher score means higher level of fatigue) | 25 weeks | 
| Likert Scale | self perception of walking stability, fear of fall, trouble with extensor thrust with a likert scale | 25 weeks | 
| Strength | strength of knee flexor and extensor muscles assessed with isokinetic dynamometer | 25 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Extensor thrust, resistance training, Isokinetic, walking speed, rehabilitation