Clinical trial NCT05887440: Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust
Official title: Effects of Isokinetic Strength Training of Knee Flexor and Extensor Muscles on Walking in Hemiparetic Patients With Knee Extension Thrust
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
Gait Disorder
Keywords: Stroke
Extensor thrust
resistance training
Isokinetic
walking speed
rehabilitation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Single Case Experimental Design (SCED)
Primary purpose: TREATMENT

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 ).

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

Primary outcomes:
measure: spontaneous walking speed
timeFrame: 25 weeks
Secondary outcomes:
measure: Extensor thrust analysis
timeFrame: 25 weeks
measure: Walking speed
timeFrame: 25 weeks
measure: Stairs test
timeFrame: 25 weeks
measure: Inclined plan
timeFrame: 25 weeks
measure: 6-minute walk test
timeFrame: 25 weeks
measure: Sit to stand test
timeFrame: 25 weeks
measure: Extensor thrust during locomotor tasks
timeFrame: 25 weeks
measure: Fatigue
timeFrame: 25 weeks
measure: Likert Scale
timeFrame: 25 weeks
measure: Strength
timeFrame: 25 weeks
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Sophie HAMEAU, PhD
role: PRINCIPAL_INVESTIGATOR
References: