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

NCT02114736 | Unknown Phase 4

• 1 other identifier: MG-SKG-57/2013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Spasticity

Keywords

Stroke; Muscle spasticity; Stiff knee gait; Botulinum toxin; Tenotomy

Outcome Measures

Primary Outcomes (1)

• Ashworth scale at the rectus femoris

  Spasticity assessment scale

  6 months

Secondary Outcomes (8)

• Stroke impairment assessment set (SIAS

  6 months

• Tardieu scale

  6 months

• MRC (Medical research Council) scale

  6 months

• Isometric muscle strenght assessment

  6 months

• 10 meter walking test

  6 months

Study Arms (2)

Rectus femoris tenotomy

EXPERIMENTAL

Surgical release of the proximal tendon of the rectus femoris

Procedure: Tenotomy of the proximal rectus femoris tendon

Botulinum toxin in the rectus femoris muscle

ACTIVE COMPARATOR

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

Drug: Botulinum Toxin injection in the rectus femoris muscle

Interventions

Tenotomy of the proximal rectus femoris tendon PROCEDURE

Surgical release of the proximal tendon of the rectus femoris

Also known as: Rectus femoris tenotomy

Rectus femoris tenotomy

Botulinum Toxin injection in the rectus femoris muscle DRUG

Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution

Also known as: Rectus femoris botulinum toxin A injections

Botulinum toxin in the rectus femoris muscle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead

Study Sites (1)

University Hospital of Mont-Godinne

Yvoir, 5530, Belgium

RECRUITING

Related Publications (3)

• 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.

  PMID: 18164331 BACKGROUND

• 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.

  PMID: 18635841 BACKGROUND

• 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.

  PMID: 20023004 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Thierry Deltombe, M.D.

  University Hospital of Mont-Godinne, Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur Clinique

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: April 15, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

BE (1)