N/A
Completed N=24
On-Track Feasibility Study of a Rehabilitation System for Stroke Patients
Cerebrovascular Accident
Source: ClinicalTrials.gov NCT03944486 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants Finding the OnTrack Intervention Acceptable in Semi Structured Interviews — 12 Participants
Summary
Feasibility study of On-Track - a digital system for upper limb rehabilitation after stroke.
Population - stroke patients over 18 years old.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Finding the OnTrack Intervention Acceptable in Semi Structured Interviews |
12 | — |
| PRIMARY Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews |
6 | — |
| SECONDARY Modified Rankin Scale |
2.8; 2.5; 1.9 | — |
| SECONDARY Fugl-Meyer Assessment for Upper Extremity (FMA-UE) |
37.7; 39; 36.4 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
22.6; 24; 25.3; 17.8; 19; 18.3 | — |
| SECONDARY Unilateral Spatial Neglect (USN) (Aka Albert's Test) |
2; 1; 1 | — |
| SECONDARY System Usability Scale (SUS) |
84.6 | — |
| SECONDARY Patient Activation and Motivation (PAM) - Questionnaire 10 Short Questions |
69.7; 65.8; 68.1 | — |
| SECONDARY Motor Assessment Log (MAL) - Questionnaire |
2.26; 2.00; 3.09; 2.94; 3.17; 3.24 | — |
| SECONDARY Visual Analogue Scale for Pain - Question |
0.8; 2.5; 2.8 | — |
| SECONDARY Friends and Family Test |
4.7 | — |
| SECONDARY EQ 5D 5L (Health Related Quality of Life) |
0.462; 0.585; 0.606 | — |
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03944486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.