Rehabilitation of Early Stroke Patients Using an AFO: an RCT

Stroke Clinical Trial

Official title:

Rehabilitation of Early Stroke Patients Using a Custom-made Solid Ankle-foot Orthosis: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01006772
• Other study ID #: PHILIPROWE1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 2, 2009
• Last updated: January 11, 2010
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2009
• Source: University of Strathclyde
• Contact: Enrica Papi, MSc, BSc
• Phone: 0141 548 3108
• Email: enrica.papi[@]strath.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Bioengineering Departent (University of Strathclyde)	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
University of Strathclyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	walking speed		every 2 weeks	Yes
Secondary	Ground reaction force value and alignment		every 12 weeks	Yes