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Recruiting NCT05887440

Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust

No phase Interventional Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis) Gait Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: isokinetic strength training of knee extensor and flexor muscles.
Who it may be relevant to
Registry conditions: Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), Gait Disorder. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 ).

Interventions

  • 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)

Primary outcome measures

  • spontaneous walking speed [Time frame: 25 weeks]
Secondary outcome measures (10)
  • Extensor thrust analysis [Time frame: 25 weeks]
  • Walking speed [Time frame: 25 weeks]
  • Stairs test [Time frame: 25 weeks]
  • Inclined plan [Time frame: 25 weeks]
  • 6-minute walk test [Time frame: 25 weeks]
  • Sit to stand test [Time frame: 25 weeks]
  • Extensor thrust during locomotor tasks [Time frame: 25 weeks]
  • Fatigue [Time frame: 25 weeks]
  • Likert Scale [Time frame: 25 weeks]
  • Strength [Time frame: 25 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU de Rennes — Rennes

Identifiers

NCT: NCT05887440 · 35RC20_9899_ISOWALK

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗