Back to resultsIsokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust (ISOWALK)
Primary Purpose
Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), Gait Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
isokinetic strength training of knee extensor and flexor muscles
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis) focused on measuring Stroke, Extensor thrust, resistance training, Isokinetic, walking speed, rehabilitation
Eligibility Criteria
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
Sites / Locations
- CHU de RennesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
3 assessments
4 assessments
5 assessments
Arm Description
The randomisation provides for 3 assessments of baseline
The randomisation provides for 4 assessments of baseline
The randomisation provides for 5 assessments of baseline
Outcomes
Primary Outcome Measures
spontaneous walking speed
Spontaneous walking speed of hemiparetic patients recorded with 3D gait analysis
Secondary Outcome Measures
Extensor thrust analysis
Extensor thrust at spontaneous and maximal walking speed and during dual task recorded with 3D gait analysis
Walking speed
assessment of walking speed in two conditions (maximal speed and dual task)
Stairs test
time to ascend and descend stairs (maximal speed)
Inclined plan
time to walk in an inclined plan (maximal speed)
6-minute walk test
Assessment of maximum gait perimeter during a 6MWT (6-minute walk test :6MWT)
Sit to stand test
1 minute sit to stand test (number of repetitions)
Extensor thrust during locomotor tasks
Extensor thrust analysis with inertial measurement unit (stairs, inclined walk, 6MWT and sit to stand )
Fatigue
Fatigue severity scale : FSS (minimum 9 -maximum 63 ; a higher score means higher level of fatigue)
Likert Scale
self perception of walking stability, fear of fall, trouble with extensor thrust with a likert scale
Strength
strength of knee flexor and extensor muscles assessed with isokinetic dynamometer
Full Information
NCT ID
NCT05887440
First Posted
April 14, 2023
Last Updated
September 1, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05887440
Brief Title
Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust
Acronym
ISOWALK
Official Title
Effects of Isokinetic Strength Training of Knee Flexor and Extensor Muscles on Walking in Hemiparetic Patients With Knee Extension Thrust
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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 ).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), Gait Disorder
Keywords
Stroke, Extensor thrust, resistance training, Isokinetic, walking speed, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Single Case Experimental Design (SCED)
Masking
Outcomes Assessor
Masking Description
Due to the nature of the intervention neither subjects nor staff can be blinded to allocation. The outcome assessors and data analyst will be blinded to research aims and randomization (multiple baseline design before introducing isokinetic strength training)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3 assessments
Arm Type
Experimental
Arm Description
The randomisation provides for 3 assessments of baseline
Arm Title
4 assessments
Arm Type
Experimental
Arm Description
The randomisation provides for 4 assessments of baseline
Arm Title
5 assessments
Arm Type
Experimental
Arm Description
The randomisation provides for 5 assessments of baseline
Intervention Type
Behavioral
Intervention Name(s)
isokinetic strength training of knee extensor and flexor muscles
Intervention Description
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)
Primary Outcome Measure Information:
Title
spontaneous walking speed
Description
Spontaneous walking speed of hemiparetic patients recorded with 3D gait analysis
Time Frame
25 weeks
Secondary Outcome Measure Information:
Title
Extensor thrust analysis
Description
Extensor thrust at spontaneous and maximal walking speed and during dual task recorded with 3D gait analysis
Time Frame
25 weeks
Title
Walking speed
Description
assessment of walking speed in two conditions (maximal speed and dual task)
Time Frame
25 weeks
Title
Stairs test
Description
time to ascend and descend stairs (maximal speed)
Time Frame
25 weeks
Title
Inclined plan
Description
time to walk in an inclined plan (maximal speed)
Time Frame
25 weeks
Title
6-minute walk test
Description
Assessment of maximum gait perimeter during a 6MWT (6-minute walk test :6MWT)
Time Frame
25 weeks
Title
Sit to stand test
Description
1 minute sit to stand test (number of repetitions)
Time Frame
25 weeks
Title
Extensor thrust during locomotor tasks
Description
Extensor thrust analysis with inertial measurement unit (stairs, inclined walk, 6MWT and sit to stand )
Time Frame
25 weeks
Title
Fatigue
Description
Fatigue severity scale : FSS (minimum 9 -maximum 63 ; a higher score means higher level of fatigue)
Time Frame
25 weeks
Title
Likert Scale
Description
self perception of walking stability, fear of fall, trouble with extensor thrust with a likert scale
Time Frame
25 weeks
Title
Strength
Description
strength of knee flexor and extensor muscles assessed with isokinetic dynamometer
Time Frame
25 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie HAMEAU, PhD
Phone
299284218
Ext
+33
Email
sophie.hameau@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Krsitell COAT
Phone
0299282555
Email
kristell.coat@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie HAMEAU, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie HAMEAU
Email
sophie.hameau@chu-rennes.fr
12. IPD Sharing Statement
Learn more about this trial
Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust
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