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NCT Number: NCT05887440

Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Rennes

Rennes, 35033, France

Location status: Recruiting

Location contact

Sophie HAMEAU

CONTACT

[email protected]

About this study

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 ).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isokinetic strength training of knee extensor and flexor muscles

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)

Primary outcomes

  1. spontaneous walking speed

    Time frame: 25 weeks

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

Secondary outcomes

  1. Extensor thrust analysis

    Time frame: 25 weeks

    Extensor thrust at spontaneous and maximal walking speed and during dual task recorded with 3D gait analysis

  2. Walking speed

    Time frame: 25 weeks

    assessment of walking speed in two conditions (maximal speed and dual task)

  3. Stairs test

    Time frame: 25 weeks

    time to ascend and descend stairs (maximal speed)

  4. Inclined plan

    Time frame: 25 weeks

    time to walk in an inclined plan (maximal speed)

  5. 6-minute walk test

    Time frame: 25 weeks

    Assessment of maximum gait perimeter during a 6MWT (6-minute walk test :6MWT)

  6. Sit to stand test

    Time frame: 25 weeks

    1 minute sit to stand test (number of repetitions)

  7. Extensor thrust during locomotor tasks

    Time frame: 25 weeks

    Extensor thrust analysis with inertial measurement unit (stairs, inclined walk, 6MWT and sit to stand )

  8. Fatigue

    Time frame: 25 weeks

    Fatigue severity scale : FSS (minimum 9 -maximum 63 ; a higher score means higher level of fatigue)

  9. Likert Scale

    Time frame: 25 weeks

    self perception of walking stability, fear of fall, trouble with extensor thrust with a likert scale

  10. Strength

    Time frame: 25 weeks

    strength of knee flexor and extensor muscles assessed with isokinetic dynamometer

Study contacts

Contact information is provided by the study sponsor or research team.

Krsitell COAT

CONTACT

[email protected]

0299282555

Sophie HAMEAU, PhD

CONTACT

[email protected]

299284218 ext. +33

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: ISOWALK

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2023
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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