Stroke Clinical Trial - Rectus Femoris Tenotomy Versus Botulinum Toxin A

Status Recruiting

Clinical Trial Summary

Stiff knee gait is defined as the lack of knee flexion in the swing phase of gait. Stiff knee gait is a frequent condition among stroke patients leading to reduce gait speed and increase energy cost. In association with neuro-rehabilitation, botulinum toxin A injections in the rectus femoris is recommended. However, the botulinum toxin A effect is transient necessitating repeated injections.

The aim of this study is to compare the benefit of the rectus femoris tenotomy in comparison with botulinum toxin A injections according to the 3 domains of the International Classification of Functioning Disability and Health of the World Health Organisation

Clinical Trial Description

INTRODUCTION

Stroke is the third cause of death and the leading cause of handicap among industrialized countries. Spasticity and co-contraction of the rectus femoris muscle following stroke is responsible for a lack of knee flexion in the swing phase of gait named stiff knee gait.

The rectus femoris spasticity is usually treated by oral medications, physical therapy and botulinum toxin A injections (1,2). As botulinum toxin A has a transient effect, injections must be repeated supporting to promote a permanent surgical treatment such as the rectus femoris tenotomy (3). However, no study has evaluate neither compare the effect of the rectus femoris tenotomy on gait and on the 3 domains of the International Classification of Functioning Disability and Health .

OBJECTIVE

To compare the effect of the rectus femoris tenotomy and of the botulinum toxin A injections for stiff knee gait after stroke according to the 3 domains of the International Classification of Functioning Disability and Health

METHODS

The investigators will recruited 20 chronic stroke patients presenting with stiff knee gait. The patients will be randomly assigned to a surgical group treated by rectus femoris tenotomy (10 patients) and to a medical group treated by rectus femoris botulinum toxin A injections.

Patients will be assessed before treatment, 2 months and 6 months after treatment by an assessor blinded therapist among the 3 domains of the International Classification of Functioning Disability and Health

PERSPECTIVE

The investigator hope to demonstrate the effectiveness of the rectus femoris tenotomy as a treatment of stiff knee gait after stroke ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02114736
Study type	Interventional
Source	University Hospital of Mont-Godinne
Contact
Status	Recruiting
Phase	Phase 4
Start date	March 2014
Completion date	December 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04043052` - Mobile Technologies and Post-stroke Depression	N/A
Recruiting	`NCT03869138` - Alternative Therapies for Improving Physical Function in Individuals With Stroke	N/A
Completed	`NCT04101695` - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects	N/A
Completed	`NCT04034069` - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial	N/A
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Completed	`NCT00391378` - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)	N/A
Recruiting	`NCT06204744` - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial	N/A
Active, not recruiting	`NCT06043167` - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting	`NCT04535479` - Dry Needling for Spasticity in Stroke	N/A
Completed	`NCT03985761` - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke	N/A
Recruiting	`NCT00859885` - International PFO Consortium	N/A
Recruiting	`NCT06034119` - Effects of Voluntary Adjustments During Walking in Participants Post-stroke	N/A
Completed	`NCT03622411` - Tablet-based Aphasia Therapy in the Chronic Phase	N/A
Completed	`NCT01662960` - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke	N/A
Recruiting	`NCT05854485` - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke	N/A
Active, not recruiting	`NCT05520528` - Impact of Group Participation on Adults With Aphasia	N/A
Completed	`NCT03366129` - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed	`NCT03281590` - Stroke and Cerebrovascular Diseases Registry
Completed	`NCT05805748` - Serious Game Therapy in Neglect Patients	N/A
Recruiting	`NCT05621980` - Finger Movement Training After Stroke	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms