Rehabilitation of Early Stroke Patients Using an AFO: an RCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01006772
Recruitment Status : Unknown
Verified November 2009 by University of Strathclyde.
Recruitment status was:  Recruiting
First Posted : November 3, 2009
Last Update Posted : January 12, 2010
Information provided by:
University of Strathclyde

Brief Summary:
Stroke is a major cause of disabilities worldwide. Stroke survivors commonly exhibit walking defects which lead to an altered, slow speed and asymmetric gait pattern. The main aims of rehabilitation are to enhance recovery of movement control and regain walking ability. Ankle-foot orthoses (AFOs), braces which encompass the foot and ankle joint extending to a point below the knee, are commonly prescribed to address ambulation impairments in stroke patients. Their main function is to support the foot and allow a subject to walk safely with a gait approaching normality. This project will aim to evaluate the early provision of AFOs as an adjunct to standard physiotherapy on the walking ability of stroke survivors. Usual rehabilitation practice will be the control condition. Participants will be recruited from the stroke unit of Stobhill Hospital in Glasgow. They will be randomised into two groups. Participants allocated in the control group will receive usual clinical practice as per routine for stroke patients. The intervention group will receive custom made solid AFOs as an adjunct. They will be provided with three AFOs, one for use during rehabilitation and two which will be used only during the outcome assessment sessions for research purposes. The intervention phase will last 24 weeks. Gait analysis will be performed three times for each participant (at baseline, 12 and 24 weeks after enrolment) in the biomechanical laboratory of Strathclyde University. During these sessions force and movement data of patients walking will be recorded. Fortnightly time and distance factors of gait will be measured and a battery of functional tasks will be performed in the physiotherapy gym of the hospital using a simple video camera and a grid lino-mat. During all assessments participants with an AFO will be asked to walk with and without the AFO provided.

Condition or disease Intervention/treatment Phase
Stroke Hemiplegia Other: Solid Ankle Foot Orthosis Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Rehabilitation of Early Stroke Patients Using a Custom-made Solid Ankle-foot Orthosis: a Randomised Controlled Trial
Study Start Date : January 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control Group
Control group patients receive usual clinical practice provided by Stroke Unit at Stobhill Hospital in Glasgow. They receive physiotherapy and early mobilisation as deemed appropriate to treat their oown impairments.
Experimental: Experimental group
Intervention Group patients receive custom made solid ankle foot orthosis (AFO)treatment.
Other: Solid Ankle Foot Orthosis
Polypropylene (homopolymer) AFO with carbon fiber reinforcements is provided to experimental group patients as an adjunct therapy to conventional physical therapy.
Other Name: Solid Ankle foot orthosis users

Primary Outcome Measures :
  1. walking speed [ Time Frame: every 2 weeks ]

Secondary Outcome Measures :
  1. Ground reaction force value and alignment [ Time Frame: every 12 weeks ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 7 days to 8 weeks after ischemic or haemorrhagic stroke, medically stable, age range between 18 and 90 years, gastrocnemius shortening with plantarflexion contracture (5 degrees of plantarflexion or greater), capable of full correction of subtalar joint, no loss of skin integrity over the lower limb, no severe cognitive impairments, sufficient communication to follow the instructions in the trial data collection procedures (follow a single one step command).

Exclusion Criteria:

  • Inability to follow simple instructions or to give informed consent, unstable angina, cardiac risks, pain related to walking, severe spasticity, the need for two assistants while walking, severe proprioceptive sensory impairment, soleus contracture which prevents casting for the AFO at 90 degrees , flexion contracture of hip musculature (greater than 10 degrees hip flexion).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01006772

Contact: Enrica Papi, MSc, BSc 0141 548 3108
Contact: Roy Bowers, Higher Diploma, MSc 0141 548 4699

United Kingdom
Bioengineering Departent (University of Strathclyde) Recruiting
Glasgow, United Kingdom, G4 ONW
Contact: Philip J Rowe, PhD, BSc, MISB    0141 548 3032   
Contact: Enrica Papi, MSc, BSc    0141 548 3108   
Principal Investigator: Enrica Papi, MSc, BSc         
Sponsors and Collaborators
University of Strathclyde
Study Director: Philip J Rowe, PhD, BSc, MISB University of Strathclyde

Responsible Party: Enrica Papi (Bioengineering Department, University of Strathclyde), University of Strathclyde Identifier: NCT01006772     History of Changes
Other Study ID Numbers: PHILIPROWE1
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: November 2009

Keywords provided by University of Strathclyde:
Ankle Foot Orthosis
Walking Speed

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms