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NCT Number: NCT06806748

Gait Recovery After Stroke

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Rivermead Mobility Index

    Time frame: From enrollment to 6 months

    Standard, patient reported outcome measure of mobility

  2. Ten meter walk test

    Time frame: From enrollment to 6 months

    Time it takes to walk 10 m. This is a well used, standardized objective test of mobility

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Kerr, PhD

CONTACT

[email protected]

+44 141 548 2855 ext. 2855

Janeesata Kuntapun, MSc

CONTACT

[email protected]

+44 141 548 0000 ext. 0000

Sponsors and collaborators

Lead sponsor

University of Strathclyde

Other

Registry information

Official study title

Observational Study of Recovery of Gait in Sub-acute Hemiplegic Stroke Patients

Acronym: GRAS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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