Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust

NCT ID: NCT05887440

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2026-12-01

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 ).

Conditions

Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis); Gait Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

3 assessments

The randomisation provides for 3 assessments of baseline

Group Type: EXPERIMENTAL

isokinetic strength training of knee extensor and flexor muscles

Intervention Type: BEHAVIORAL

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)

4 assessments

The randomisation provides for 4 assessments of baseline

Group Type: EXPERIMENTAL

isokinetic strength training of knee extensor and flexor muscles

Intervention Type: BEHAVIORAL

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)

5 assessments

The randomisation provides for 5 assessments of baseline

Group Type: EXPERIMENTAL

isokinetic strength training of knee extensor and flexor muscles

Intervention Type: BEHAVIORAL

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)

Interventions

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)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie HAMEAU, PhD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

CHU de Rennes

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sophie HAMEAU, PhD

Role: CONTACT

sophie.hameau@chu-rennes.fr

299284218 ext. +33

Krsitell COAT

Role: CONTACT

kristell.coat@chu-rennes.fr

0299282555

Facility Contacts

Sophie HAMEAU

Role: primary

sophie.hameau@chu-rennes.fr

Other Identifiers

35RC20_9899_ISOWALK

Identifier Type: -

Identifier Source: org_study_id