Gait Recovery After Stroke

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT06806748
• Lead Sponsor: University of Strathclyde

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04
• Study Start: 2025-08-01
• Primary Completion: 2027-02-01
• Study Completion: 2027-05-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gait symmetry	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

Secondary Outcome Measures

Name	Time	Method
Rivermead Mobility Index	From enrollment to 6 months	Standard, patient reported outcome measure of mobility
Ten meter walk test	From enrollment to 6 months	Time it takes to walk 10 m. This is a well used, standardized objective test of mobility