Clinical trial NCT06806748: Gait Recovery After Stroke
Official title: Observational Study of Recovery of Gait in Sub-acute Hemiplegic Stroke Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Keywords: Observational, gait, symmetry
Lead sponsor: University of Strathclyde
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sub-acute stroke patients with hemiplegia who are referred for rehabilitation

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Gait symmetry
timeFrame: From enrollment to 6 months
Secondary outcomes:
measure: Rivermead Mobility Index
timeFrame: From enrollment to 6 months
measure: Ten meter walk test
timeFrame: From enrollment to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Strathclyde
name: Andrew Kerr, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: