Rehabilitation of Early Stroke Patients Using an AFO: an RCT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01006772|
Recruitment Status : Unknown
Verified November 2009 by University of Strathclyde.
Recruitment status was: Recruiting
First Posted : November 3, 2009
Last Update Posted : January 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiplegia||Other: Solid Ankle Foot Orthosis||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||September 2011|
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
- walking speed [ Time Frame: every 2 weeks ]
- Ground reaction force value and alignment [ Time Frame: every 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|