NCT06806748

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Aug 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Aug 2025May 2027

First Submitted

Initial submission to the registry

January 28, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2027

Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

January 28, 2025

Last Update Submit

January 28, 2025

Conditions

Stroke

Keywords

Observational, gait, symmetry

Outcome Measures

Primary Outcomes (1)

  • 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

    From enrollment to 6 months

Secondary Outcomes (2)

  • Rivermead Mobility Index

    From enrollment to 6 months

  • Ten meter walk test

    From enrollment to 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sub-acute stroke patients with hemiplegia who are referred for rehabilitation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andrew Kerr, Ph.D

    University of Strathclyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Kerr, PhD

CONTACT

+44 141 548 2855a.kerr@strath.ac.uk

Janeesata Kuntapun, MSc

CONTACT

+44 141 548 0000janeesata.kuntapun.2022@strath.ac.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 4, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 10, 2027

Last Updated

February 4, 2025

Record last verified: 2025-01