StrokeGRASNCT06806748
Gait Recovery After Stroke
An observational study of Stroke, run by University of Strathclyde.
Trial summary
The purpose of this observational study is to track the recovery of stance duration symmetry during the first 6 months after stroke using wearable sensors and explore the influence of stroke specific factors (time since stroke, stroke type, location and paretic side). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 10 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sub-acute stroke patients with hemiplegia who are referred for rehabilitation
Who may be able to join
- aged 18 or older
- diagnosis of a first occurrence of stroke by consultant stroke physician
- Medically stable
- referred for rehabilitation
- functional ambulatory category of 1 and over
Who cannot join
- acute skin condition
- transient ischemic stroke
- comorbidities that may interfere with walking function, such as Parkinson's disease or lower limb amputation
- severe communication impairments or delirium
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Observational Study of Recovery of Gait in Sub-acute Hemiplegic Stroke Patients
The purpose of this observational study is to track the recovery of stance duration symmetry during the first 6 months after stroke using wearable sensors and explore the influence of stroke specific factors (time since stroke, stroke type, location and paretic side).
Read the detailed description
Gait impairments can limit the ability to perform daily activities and increase the risk of falls in stroke survivors. Although rehabilitation improves walking in people with stroke, it is unclear whether the improvement relies on compensatory strategies or can be further improved to achieve normal or closer to normal performance.
Stance duration symmetry is an ideal measure of gait recovery in stroke survivors as it indicates the paretic sides capacity to control body weight and maintain balance during walking. Measuring stance duration symmetry may, therefore, be useful for monitoring gait recovery and could be considered as one of key goals in stroke rehabilitation.
Understanding the mechanisms of gait recovery in people with stroke is, therefore, essential for designing treatment program, setting realistic goals and appropriate timing for promoted intervention according to their stroke characteristics.
Our plan is to track changes in the symmetry of stance duration of hemiplegic patients during the first 6 months after stroke attached at the following time points: 1) at recruitment (within 2 weeks after of stroke), 2) 4th weeks (1 month) after stroke, 3) 12th weeks (3 months) after stroke, and 4) 26th weeks (6 months) after stroke. Two wearable accelerometers (the ActivPAL4+, PAL technology, Glasgow, UK) directly to the skin of both anterior thighs using sticky pads for 4 days (24 hours) period. Demographic (age and gender) and relevant clinical data (10-meter walk test, Modified Rivermead Mobility Index (RMI), stroke type, paretic side) will also be recorded as factors to explain gait symmetry.
- Conditions
- Stroke
- Keywords
- Observational, gait, symmetry
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait symmetry
Gait symmetry will be measured from the signals produced by two thigh mounted inertial motion units. The variable of prime interest is the difference in stance duration between the hemiplegic and non-hemiplegic sides
Measured: From enrollment to 6 months
Secondary outcomes (2)
Rivermead Mobility Index
Standard, patient reported outcome measure of mobility
Measured: From enrollment to 6 months
Ten meter walk test
Time it takes to walk 10 m. This is a well used, standardized objective test of mobility
Measured: From enrollment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion10 May 2027 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Strathclyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Kerr, Ph.D, Principal investigator, University of Strathclyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806748
- Sponsor's protocol ID
- UoS_GRAS_2025
- Acronym
- GRAS
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Recovery of Gait in Sub-acute Hemiplegic Stroke Patients
- ClinicalTrials.gov ID
- NCT06806748
- Acronym / sponsor ID
- GRAS / UoS_GRAS_2025
- Conditions
- Stroke
- Keywords
- Observational, gait, symmetry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of StrathclydeUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 4 Feb 2025 (actual)
- 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.
The purpose of this observational study is to track the recovery of stance duration symmetry during the first 6 months after stroke using wearable sensors and explore the influence of stroke specific factors (time since stroke, stroke type, location and paretic side).
Detailed description
Gait impairments can limit the ability to perform daily activities and increase the risk of falls in stroke survivors. Although rehabilitation improves walking in people with stroke, it is unclear whether the improvement relies on compensatory strategies or can be further improved to achieve normal or closer to normal performance.
Stance duration symmetry is an ideal measure of gait recovery in stroke survivors as it indicates the paretic sides capacity to control body weight and maintain balance during walking. Measuring stance duration symmetry may, therefore, be useful for monitoring gait recovery and could be considered as one of key goals in stroke rehabilitation.
Understanding the mechanisms of gait recovery in people with stroke is, therefore, essential for designing treatment program, setting realistic goals and appropriate timing for promoted intervention according to their stroke characteristics.
Our plan is to track changes in the symmetry of stance duration of hemiplegic patients during the first 6 months after stroke attached at the following time points: 1) at recruitment (within 2 weeks after of stroke), 2) 4th weeks (1 month) after stroke, 3) 12th weeks (3 months) after stroke, and 4) 26th weeks (6 months) after stroke. Two wearable accelerometers (the ActivPAL4+, PAL technology, Glasgow, UK) directly to the skin of both anterior thighs using sticky pads for 4 days (24 hours) period. Demographic (age and gender) and relevant clinical data (10-meter walk test, Modified Rivermead Mobility Index (RMI), stroke type, paretic side) will also be recorded as factors to explain gait symmetry.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sub-acute stroke patients with hemiplegia who are referred for rehabilitation
Key inclusion criteria (5 listed)
- aged 18 or older
- diagnosis of a first occurrence of stroke by consultant stroke physician
- Medically stable
- referred for rehabilitation
- functional ambulatory category of 1 and over
Key exclusion criteria (4 listed)
- acute skin condition
- transient ischemic stroke
- comorbidities that may interfere with walking function, such as Parkinson's disease or lower limb amputation
- severe communication impairments or delirium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gait symmetry
Time frame: From enrollment to 6 months
Gait symmetry will be measured from the signals produced by two thigh mounted inertial motion units. The variable of prime interest is the difference in stance duration between the hemiplegic and non-hemiplegic sides
2 secondary outcomes
Rivermead Mobility Index
Time frame: From enrollment to 6 months
Ten meter walk test
Time frame: From enrollment to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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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.
Andrew Kerr, Ph.D principal investigator
University of Strathclyde
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Strathclyde.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Kerr, PhD (+44 141 548 2855 ext. 2855, a.kerr@strath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait symmetry (time frame: From enrollment to 6 months). 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 4 Feb 2025.