Rehabilitation of Early Stroke Patients Using an AFO: an RCT

NCT ID: NCT01006772

Last Updated: 2010-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-09-30

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.

Conditions

Stroke; Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

Intervention Group patients receive custom made solid ankle foot orthosis (AFO)treatment.

Group Type: EXPERIMENTAL

Solid Ankle Foot Orthosis

Intervention Type: OTHER

Polypropylene (homopolymer) AFO with carbon fiber reinforcements is provided to experimental group patients as an adjunct therapy to conventional physical therapy.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Solid Ankle foot orthosis users

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Strathclyde

OTHER

Sponsor Role: lead

Responsible Party

University of Strathclyde

Principal Investigators

Philip J Rowe, PhD, BSc, MISB

Role: STUDY_DIRECTOR

University of Strathclyde

Locations

Bioengineering Departent (University of Strathclyde)

Glasgow, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Enrica Papi, MSc, BSc

Role: CONTACT

enrica.papi@strath.ac.uk

0141 548 3108

Roy Bowers, Higher Diploma, MSc

Role: CONTACT

r.j.bowers@strath.ac.uk

0141 548 4699

Facility Contacts

Philip J Rowe, PhD, BSc, MISB

Role: primary

philip.rowe@strath.ac.uk

0141 548 3032

Enrica Papi, MSc, BSc

Role: backup

enrica.papi@strath.ac.uk

0141 548 3108

Other Identifiers

PHILIPROWE1

Identifier Type: -

Identifier Source: org_study_id