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Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05887440
Acronym
ISOWALK
Enrollment
12
Registered
2023-06-02
Start date
2023-08-21
Completion date
2026-12-01
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Stroke, Extensor thrust, resistance training, Isokinetic, walking speed, rehabilitation

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 ).

Interventions

BEHAVIORALisokinetic 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)

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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)

Intervention model description

Single Case Experimental Design (SCED)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
spontaneous walking speed25 weeksSpontaneous walking speed of hemiparetic patients recorded with 3D gait analysis

Secondary

MeasureTime frameDescription
Walking speed25 weeksassessment of walking speed in two conditions (maximal speed and dual task)
Stairs test25 weekstime to ascend and descend stairs (maximal speed)
Inclined plan25 weekstime to walk in an inclined plan (maximal speed)
6-minute walk test25 weeksAssessment of maximum gait perimeter during a 6MWT (6-minute walk test :6MWT)
Extensor thrust analysis25 weeksExtensor thrust at spontaneous and maximal walking speed and during dual task recorded with 3D gait analysis
Extensor thrust during locomotor tasks25 weeksExtensor thrust analysis with inertial measurement unit (stairs, inclined walk, 6MWT and sit to stand )
Fatigue25 weeksFatigue severity scale : FSS (minimum 9 -maximum 63 ; a higher score means higher level of fatigue)
Likert Scale25 weeksself perception of walking stability, fear of fall, trouble with extensor thrust with a likert scale
Strength25 weeksstrength of knee flexor and extensor muscles assessed with isokinetic dynamometer
Sit to stand test25 weeks1 minute sit to stand test (number of repetitions)

Countries

France

Contacts

Primary ContactSophie HAMEAU, PhD
sophie.hameau@chu-rennes.fr299284218
Backup ContactKrsitell COAT
kristell.coat@chu-rennes.fr0299282555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026