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Clinical Trials/NCT05887440
NCT05887440
Recruiting
Not Applicable

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

Rennes University Hospital1 site in 1 country12 target enrollmentAugust 21, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
Sponsor
Rennes University Hospital
Enrollment
12
Locations
1
Primary Endpoint
spontaneous walking speed
Status
Recruiting
Last Updated
2 years ago

Overview

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 ).

Registry
clinicaltrials.gov
Start Date
August 21, 2023
End Date
December 1, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

spontaneous walking speed

Time Frame: 25 weeks

Spontaneous walking speed of hemiparetic patients recorded with 3D gait analysis

Secondary Outcomes

  • 6-minute walk test(25 weeks)
  • Extensor thrust analysis(25 weeks)
  • Walking speed(25 weeks)
  • Stairs test(25 weeks)
  • Inclined plan(25 weeks)
  • Extensor thrust during locomotor tasks(25 weeks)
  • Sit to stand test(25 weeks)
  • Fatigue(25 weeks)
  • Likert Scale(25 weeks)
  • Strength(25 weeks)

Study Sites (1)

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