Rehabilitation of Early Stroke Patients Using an AFO: an RCT

NCT01006772 | Unknown Phase 1

• 1 other identifier: PHILIPROWE1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; Ankle Foot Orthosis; Walking Speed; Gait; Rehabilitation; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• walking speed

  every 2 weeks

Secondary Outcomes (1)

• Ground reaction force value and alignment

  every 12 weeks

Study Arms (2)

Control Group

NO INTERVENTION

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 group

EXPERIMENTAL

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

Other: Solid Ankle Foot Orthosis

Interventions

Solid Ankle Foot Orthosis OTHER

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

Also known as: Solid Ankle foot orthosis users

Experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Strathclyde: lead

Study Sites (1)

Bioengineering Departent (University of Strathclyde)

Glasgow, G4 ONW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip J Rowe, PhD, BSc, MISB

  University of Strathclyde

  STUDY DIRECTOR

Central Study Contacts

Enrica Papi, MSc, BSc

CONTACT

0141 548 3108; enrica.papi@strath.ac.uk

Roy Bowers, Higher Diploma, MSc

CONTACT

0141 548 4699; r.j.bowers@strath.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 3, 2009
• Study Start: January 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 12, 2010

Record last verified: 2009-11

Locations

GB (1)