Rehabilitation of Early Stroke Patients Using an AFO: an RCT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Strathclyde.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Strathclyde
ClinicalTrials.gov Identifier:
NCT01006772
First received: November 2, 2009
Last updated: January 11, 2010
Last verified: November 2009
  Purpose

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 Intervention Phase
Stroke
Hemiplegia
Other: Solid Ankle Foot Orthosis
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Strathclyde:

Primary Outcome Measures:
  • walking speed [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ground reaction force value and alignment [ Time Frame: every 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006772

Contacts
Contact: Enrica Papi, MSc, BSc 0141 548 3108 enrica.papi@strath.ac.uk
Contact: Roy Bowers, Higher Diploma, MSc 0141 548 4699 r.j.bowers@strath.ac.uk

Locations
United Kingdom
Bioengineering Departent (University of Strathclyde) Recruiting
Glasgow, United Kingdom, G4 ONW
Contact: Philip J Rowe, PhD, BSc, MISB    0141 548 3032    philip.rowe@strath.ac.uk   
Contact: Enrica Papi, MSc, BSc    0141 548 3108    enrica.papi@strath.ac.uk   
Principal Investigator: Enrica Papi, MSc, BSc         
Sponsors and Collaborators
University of Strathclyde
Investigators
Study Director: Philip J Rowe, PhD, BSc, MISB University of Strathclyde
  More Information

No publications provided

Responsible Party: Enrica Papi (Bioengineering Department, University of Strathclyde), University of Strathclyde
ClinicalTrials.gov Identifier: NCT01006772     History of Changes
Other Study ID Numbers: PHILIPROWE1
Study First Received: November 2, 2009
Last Updated: January 11, 2010
Health Authority: United Kingdom: Department of Health

Keywords provided by University of Strathclyde:
Stroke
Ankle Foot Orthosis
Walking Speed
Gait
Rehabilitation
Hemiplegia

Additional relevant MeSH terms:
Hemiplegia
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014