Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust (ISOWALK)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gait Disorder; Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
• Intervention / Treatment: Behavioral: isokinetic strength training of knee extensor and flexor muscles

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 ).

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie HAMEAU, PhD; Phone Number: +33 299284218; Email: sophie.hameau@chu-rennes.fr
• Study Contact Backup: Name: Krsitell COAT; Phone Number: 0299282555; Email: kristell.coat@chu-rennes.fr

Study Locations

• France
  • Rennes, France, 35033
    • Recruiting
    • CHU de Rennes
    • Contact: Sophie HAMEAU; Email: sophie.hameau@chu-rennes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 assessments; The randomisation provides for 3 assessments of baseline	Behavioral: isokinetic strength training of knee extensor and flexor muscles; 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)
Experimental: 4 assessments; The randomisation provides for 4 assessments of baseline	Behavioral: isokinetic strength training of knee extensor and flexor muscles; 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)
Experimental: 5 assessments; The randomisation provides for 5 assessments of baseline	Behavioral: isokinetic strength training of knee extensor and flexor muscles; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Sophie HAMEAU, PhD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; rehabilitation; resistance training; walking speed; Isokinetic; Extensor thrust
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia; Paresis
• Other Study ID Numbers: 35RC20_9899_ISOWALK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No