NCT05887440

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Aug 2023Dec 2026

First Submitted

Initial submission to the registry

April 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 21, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

April 14, 2023

Last Update Submit

September 1, 2023

Conditions

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

Keywords

StrokeExtensor thrustresistance trainingIsokineticwalking speedrehabilitation

Outcome Measures

Primary Outcomes (1)

  • spontaneous walking speed

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

    25 weeks

Secondary Outcomes (10)

  • Extensor thrust analysis

    25 weeks

  • Walking speed

    25 weeks

  • Stairs test

    25 weeks

  • Inclined plan

    25 weeks

  • 6-minute walk test

    25 weeks

  • +5 more secondary outcomes

Study Arms (3)

3 assessments

EXPERIMENTAL

The randomisation provides for 3 assessments of baseline

Behavioral: isokinetic strength training of knee extensor and flexor muscles

4 assessments

EXPERIMENTAL

The randomisation provides for 4 assessments of baseline

Behavioral: isokinetic strength training of knee extensor and flexor muscles

5 assessments

EXPERIMENTAL

The randomisation provides for 5 assessments of baseline

Behavioral: isokinetic strength training of knee extensor and flexor muscles

Interventions

isokinetic strength training of knee extensor and flexor musclesBEHAVIORAL

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)

3 assessments4 assessments5 assessments

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

RECRUITING

MeSH Terms

Conditions

ParesisHemiplegiaMobility LimitationStroke

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsParalysisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sophie HAMEAU, PhD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie HAMEAU, PhD

CONTACT

299284218sophie.hameau@chu-rennes.fr

Krsitell COAT

CONTACT

0299282555kristell.coat@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the intervention neither subjects nor staff can be blinded to allocation. The outcome assessors and data analyst will be blinded to research aims and randomization (multiple baseline design before introducing isokinetic strength training)
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Single Case Experimental Design (SCED)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

June 2, 2023

Study Start

August 21, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 5, 2023

Record last verified: 2023-09

Locations

FR(1)