Rehabilitation of Early Stroke Patients Using an AFO: an RCT
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- walking speed [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
- Ground reaction force value and alignment [ Time Frame: every 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006772
|Contact: Enrica Papi, MSc, BSc||0141 548 firstname.lastname@example.org|
|Contact: Roy Bowers, Higher Diploma, MSc||0141 548 email@example.com|
|Bioengineering Departent (University of Strathclyde)||Recruiting|
|Glasgow, United Kingdom, G4 ONW|
|Contact: Philip J Rowe, PhD, BSc, MISB 0141 548 3032 firstname.lastname@example.org|
|Contact: Enrica Papi, MSc, BSc 0141 548 3108 email@example.com|
|Principal Investigator: Enrica Papi, MSc, BSc|
|Study Director:||Philip J Rowe, PhD, BSc, MISB||University of Strathclyde|