On-Track Feasibility Study of a Rehabilitation System for Stroke Patients

NCT03944486 | Completed Results

• 1 other identifier: 19SM5146
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility study of On-Track - a digital system for upper limb rehabilitation after stroke. Population - stroke patients over 18 years old.

Conditions

Cerebrovascular Accident

Keywords

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (2)

• Number of Participants Finding the OnTrack Intervention Acceptable in Semi Structured Interviews

  Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of OnTrack. Interviews determine whether participants found the intervention easy to use and acceptable and if it is fit for their rehabilitation needs.

  Week 13

• Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews

  To assess the feasibility of the study design and procedures. Semi structured interviews will aim to collect therapists opinions on the strengths and weaknesses of On-Track.

  Week 13

Secondary Outcomes (10)

• Modified Rankin Scale

  Baseline, follow-up (week 7), follow-up (week 13)

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  Baseline, follow-up (week 7), follow-up (week 13)

• Montreal Cognitive Assessment (MoCA)

  Baseline, follow-up (week 7), follow-up (week 13)

• Unilateral Spatial Neglect (USN) (Aka Albert's Test)

  Baseline, follow-up (week 7), follow-up (week 13)

• System Usability Scale (SUS)

  Week 13

Study Arms (1)

On-Track

OTHER

Stroke survivors receiving the OnTrack intervention for 12 weeks consisting of arm activity tracking and self-management coaching. Assessments are done before and after the intervention.

Device: Feasibility of OnTrack

Interventions

Feasibility of OnTrack DEVICE

Patients to use digital application- study assessed the feasibility of the application for patients and therapists.

On-Track

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (aged 18 or over).
• Stroke diagnosis less than 6 months previously (first or recurrent). Some participants will be recruited from an in-patient rehabilitation ward, hence the 6-month poststroke limit.
• Arm impairment of any type or level (including weakness-including dense hemiplegia, neglect and sensory deficits). This enables better understanding of which impairment level groups could benefit or not from using the intervention, especially considering the impact it may have on people's motivation regardless of their level of impairment.
• Ability to provide informed consent.
• Reliability to communicate (verbally or non-verbally) and understand English.
• Ability to read a predefined short message.

You may not qualify if:

• Unstable medical condition.
• Self-reported 'severe' pain in the arm affected either at rest or during movement.
• Severe oedema in the arm affected by their stroke, judged by the consenting therapist.
• Known discharge plans to a hospital other than the recruitment site or residential care in less than 7 weeks (a small proportion of patients in in-patient rehab may be in hospital for up to 12 weeks).
• Participants who are unable to engage with the intervention for a period of more than 7 consecutive days will be reviewed in a case-by-case basis by the members of the team responsible for delivering the intervention to determine if study continuation is appropriate.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial Collage NHS Healthcare Trust

London, W12 0HS, United Kingdom

Location

Related Publications (3)

• Taylor E, Fusari G, Darzi A, Jones F. Is a novel digital system for arm and hand rehabilitation suitable for stroke survivors? A qualitative process evaluation of OnTrack. BMJ Open. 2023 Aug 18;13(8):e062119. doi: 10.1136/bmjopen-2022-062119.

  PMID: 37597873 DERIVED

• Fusari G, Gibbs E, Hoskin L, Lawrence-Jones A, Dickens D, Fernandez Crespo R, Leis M, Crow J, Taylor E, Jones F, Darzi A. What is the feasibility and patient acceptability of a digital system for arm and hand rehabilitation after stroke? A mixed-methods, single-arm feasibility study of the 'OnTrack' intervention for hospital and home use. BMJ Open. 2022 Sep 28;12(9):e062042. doi: 10.1136/bmjopen-2022-062042.

  PMID: 36171046 DERIVED

• Fusari G, Gibbs E, Hoskin L, Dickens D, Leis M, Taylor E, Jones F, Darzi A. Protocol for a feasibility study of OnTrack: a digital system for upper limb rehabilitation after stroke. BMJ Open. 2020 Mar 23;10(3):e034936. doi: 10.1136/bmjopen-2019-034936.

  PMID: 32205375 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Research Integrity Officer
• Organization: Imperial College London

e.magnusson@imperial.ac.uk

+44 (0)20 7594 1872

Study Officials

• Ara Darzi, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 9, 2019
• Study Start: August 13, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2021
• Last Updated: March 12, 2024
• Results First Posted: March 29, 2022

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)