Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust

Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis) Clinical Trial

— ISOWALK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887440
• Other study ID #: 35RC20_9899_ISOWALK
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: September 2023
• Source: Rennes University Hospital
• Contact: Sophie HAMEAU, PhD
• Phone: 299284218
• Email: sophie.hameau[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 ).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spontaneous walking speed	Spontaneous walking speed of hemiparetic patients recorded with 3D gait analysis	25 weeks
Secondary	Extensor thrust analysis	Extensor thrust at spontaneous and maximal walking speed and during dual task recorded with 3D gait analysis	25 weeks
Secondary	Walking speed	assessment of walking speed in two conditions (maximal speed and dual task)	25 weeks
Secondary	Stairs test	time to ascend and descend stairs (maximal speed)	25 weeks
Secondary	Inclined plan	time to walk in an inclined plan (maximal speed)	25 weeks
Secondary	6-minute walk test	Assessment of maximum gait perimeter during a 6MWT (6-minute walk test :6MWT)	25 weeks
Secondary	Sit to stand test	1 minute sit to stand test (number of repetitions)	25 weeks
Secondary	Extensor thrust during locomotor tasks	Extensor thrust analysis with inertial measurement unit (stairs, inclined walk, 6MWT and sit to stand )	25 weeks
Secondary	Fatigue	Fatigue severity scale : FSS (minimum 9 -maximum 63 ; a higher score means higher level of fatigue)	25 weeks
Secondary	Likert Scale	self perception of walking stability, fear of fall, trouble with extensor thrust with a likert scale	25 weeks
Secondary	Strength	strength of knee flexor and extensor muscles assessed with isokinetic dynamometer	25 weeks