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

Rennes University Hospital

Status: Enrolling

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

Treatments: Behavioral: isokinetic strength training of knee extensor and flexor muscles

Study type: Interventional

Funder types: Other

Identifiers

NCT05887440

35RC20_9899_ISOWALK

Details and patient eligibility

About

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.

Full 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 ).

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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12 participants in 3 patient groups

3 assessments

Experimental group

Description:

The randomisation provides for 3 assessments of baseline

Treatment:

Behavioral: isokinetic strength training of knee extensor and flexor muscles

4 assessments

Experimental group

Description:

The randomisation provides for 4 assessments of baseline

Treatment:

Behavioral: isokinetic strength training of knee extensor and flexor muscles

5 assessments

Experimental group

Description:

The randomisation provides for 5 assessments of baseline

Treatment:

Behavioral: isokinetic strength training of knee extensor and flexor muscles