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

Primary Purpose

Stroke, Spasticity

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Tenotomy of the proximal rectus femoris tendon
Botulinum Toxin injection in the rectus femoris muscle
Sponsored by
University Hospital of Mont-Godinne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Muscle spasticity, Stiff knee gait, Botulinum toxin, Tenotomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stroke lasting for more than 6 months
  • stiff knee gait
  • rectus femoris spasticity (> Ashworth 2)
  • transient improvement with previous botulinum toxine A injection in the rectus femoris
  • stiff knee gait improved after rectus femoris diagnostic motor nere block
  • able to walk on treadmill

Exclusion Criteria:

  • pregnant women
  • botulinum toxin A injections in the rectus femoris < 6 months
  • previous surgery for stiff knee gait

Sites / Locations

  • University Hospital of Mont-GodinneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rectus femoris tenotomy

Botulinum toxin in the rectus femoris muscle

Arm Description

Surgical release of the proximal tendon of the rectus femoris

Botulinum toxin (200U Botox) injection in the rectus femoris muscle

Outcomes

Primary Outcome Measures

Ashworth scale at the rectus femoris
Spasticity assessment scale

Secondary Outcome Measures

Stroke impairment assessment set (SIAS
Body function and structure scale for stroke patients
Tardieu scale
Spasiticty assessment scale
MRC (Medical research Council) scale
Muscle strength scale
Isometric muscle strenght assessment
Objective muscle strenght with isometric dynamometer
10 meter walking test
Gait speed assessment scale
Instrumented gait analysis
Kinetic and kinematic gait assessment in gait laboratory
ABILOCO scale
Activity level scale for gait validated according to Rasch model
EQ-5D-5L scale
Health quality of life scale

Full Information

First Posted
March 19, 2014
Last Updated
April 12, 2014
Sponsor
University Hospital of Mont-Godinne
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1. Study Identification

Unique Protocol Identification Number
NCT02114736
Brief Title
Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke
Official Title
A Randomized Controlled Trial of Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Mont-Godinne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spasticity
Keywords
Stroke, Muscle spasticity, Stiff knee gait, Botulinum toxin, Tenotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rectus femoris tenotomy
Arm Type
Experimental
Arm Description
Surgical release of the proximal tendon of the rectus femoris
Arm Title
Botulinum toxin in the rectus femoris muscle
Arm Type
Active Comparator
Arm Description
Botulinum toxin (200U Botox) injection in the rectus femoris muscle
Intervention Type
Procedure
Intervention Name(s)
Tenotomy of the proximal rectus femoris tendon
Other Intervention Name(s)
Rectus femoris tenotomy
Intervention Description
Surgical release of the proximal tendon of the rectus femoris
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin injection in the rectus femoris muscle
Other Intervention Name(s)
Rectus femoris botulinum toxin A injections
Intervention Description
Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution
Primary Outcome Measure Information:
Title
Ashworth scale at the rectus femoris
Description
Spasticity assessment scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Stroke impairment assessment set (SIAS
Description
Body function and structure scale for stroke patients
Time Frame
6 months
Title
Tardieu scale
Description
Spasiticty assessment scale
Time Frame
6 months
Title
MRC (Medical research Council) scale
Description
Muscle strength scale
Time Frame
6 months
Title
Isometric muscle strenght assessment
Description
Objective muscle strenght with isometric dynamometer
Time Frame
6 months
Title
10 meter walking test
Description
Gait speed assessment scale
Time Frame
6 months
Title
Instrumented gait analysis
Description
Kinetic and kinematic gait assessment in gait laboratory
Time Frame
6 months
Title
ABILOCO scale
Description
Activity level scale for gait validated according to Rasch model
Time Frame
6 months
Title
EQ-5D-5L scale
Description
Health quality of life scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke lasting for more than 6 months stiff knee gait rectus femoris spasticity (> Ashworth 2) transient improvement with previous botulinum toxine A injection in the rectus femoris stiff knee gait improved after rectus femoris diagnostic motor nere block able to walk on treadmill Exclusion Criteria: pregnant women botulinum toxin A injections in the rectus femoris < 6 months previous surgery for stiff knee gait
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Deltombe, M.D.
Organizational Affiliation
University Hospital of Mont-Godinne, Université Catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Deltombe, M.D.
Phone
+ 32 81 42 37 72
Email
thierry.deltombe@uclouvain.be

12. IPD Sharing Statement

Citations:
PubMed Identifier
18164331
Citation
Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.
Results Reference
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PubMed Identifier
18635841
Citation
Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of simultaneous botulinum toxin injections into several muscles on impairment, activity, participation, and quality of life among stroke patients presenting with a stiff knee gait. Stroke. 2008 Oct;39(10):2803-8. doi: 10.1161/STROKEAHA.108.516153. Epub 2008 Jul 17.
Results Reference
background
PubMed Identifier
20023004
Citation
Namdari S, Pill SG, Makani A, Keenan MA. Rectus femoris to gracilis muscle transfer with fractional lengthening of the vastus muscles: a treatment for adults with stiff knee gait. Phys Ther. 2010 Feb;90(2):261-8. doi: 10.2522/ptj.20090151. Epub 2009 Dec 18.
Results Reference
background

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

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