StrokePhase 1/2NCT01006772
Rehabilitation of Early Stroke Patients Using an AFO: an RCT
A Phase 1/2 study testing Solid Ankle Foot Orthosis in people with Stroke and Hemiplegia, run by University of Strathclyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Solid Ankle Foot Orthosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Sep 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Bioengineering Departent (University of Strathclyde)
Glasgow, G4 ONW
Philip J Rowe, PhD, BSc, MISB, 0141 548 3032, philip.rowe@strath.ac.uk
Enrica Papi, MSc, BSc, 0141 548 3108, enrica.papi@strath.ac.uk
About this study
Official title: Rehabilitation of Early Stroke Patients Using a Custom-made Solid Ankle-foot Orthosis: a Randomised Controlled Trial
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
- Being tested
- Solid Ankle Foot Orthosis
- Keywords
- Stroke, Ankle Foot Orthosis, Walking Speed, Gait, Rehabilitation, Hemiplegia
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solid Ankle Foot OrthosisOther
Also called Solid Ankle foot orthosis users
Polypropylene (homopolymer) AFO with carbon fiber reinforcements is provided to experimental group patients as an adjunct therapy to conventional physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Solid Ankle Foot Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed
Measured: every 2 weeks
Secondary outcomes (1)
Ground reaction force value and alignment
Measured: every 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Strathclyde
- Sponsor type
- University, hospital or other
- Investigators
- Philip J Rowe, PhD, BSc, MISB, Study director, University of Strathclyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006772
- Sponsor's protocol ID
- PHILIPROWE1
- Status last verified
- Nov 2009
- First submitted
- 2 Nov 2009
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Early Stroke Patients Using a Custom-made Solid Ankle-foot Orthosis: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01006772
- Acronym / sponsor ID
- PHILIPROWE1
- Conditions
- Stroke, Hemiplegia
- Keywords
- Stroke, Ankle Foot Orthosis, Walking Speed, Gait, Rehabilitation, Hemiplegia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of StrathclydeUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Solid Ankle Foot OrthosisIntervention Group patients receive custom made solid ankle foot orthosis (AFO)treatment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solid Ankle Foot OrthosisAlso: Solid Ankle foot orthosis usersPolypropylene (homopolymer) AFO with carbon fiber reinforcements is provided to experimental group patients as an adjunct therapy to conventional physical therapy. | Other | Experimental group |
Primary outcome
walking speed
Time frame: every 2 weeks
1 secondary outcome
Ground reaction force value and alignment
Time frame: every 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip J Rowe, PhD, BSc, MISB study director
University of Strathclyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Solid Ankle Foot Orthosis in people with Stroke and Hemiplegia, run by University of Strathclyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrica Papi, MSc, BSc (0141 548 3108, enrica.papi@strath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walking speed (time frame: every 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.