Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04475692 |
Other study ID # |
20CX5959 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2021 |
Est. completion date |
June 30, 2023 |
Study information
Verified date |
October 2023 |
Source |
Imperial College London |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
A pilot multicentre randomised control trial (RCT), examining upper limb (UL) outcomes
amongst stroke survivors implementing a technology-based, self-directed UL intervention as an
adjunct to conventional care.
Description:
Title: A multicentre pilot randomised control trial (RCT) of an adapted mobile rehabilitation
system (GripAble) for self-directed upper limb (UL) rehabilitation and improved UL outcomes
in stroke survivors with UL weakness.
Design: Interventional (clinical trial). A multicentre pilot RCT, parallel design, comparing
intervention group (self-selected dose of self-directed technology-based UL exercise as an
adjunct to conventional care) with a control group receiving conventional care only. A mixed
methods research design will be implemented. This will be an assessor-blinded protocol, due
to the nature of the intervention, participants cannot be blinded. This will be an internal
pilot, if no changes are made to the protocol and additional funding is secured, the data
from this pilot work will be used be used as part of an adequately powered RCT.
Aims: To test research design considerations in preparation for a definitive multicentre RCT.
To explore the hypothesis that stroke survivors with UL weakness will engage in self-directed
exercise (without direct professional supervision) as an adjunct to conventional care and
demonstrate significant improvement in UL outcomes when provided with an adapted mobile
rehabilitation system, compared with a control group participating in conventional care only.
Outcome Measures: The primary end point outcome will be based on intention to treat analysis
on the Fugl Meyer Upper Extremity Assessment (FM-UE) at 6months post randomisation,
controlled for baseline.
Additional/ secondary outcome measures will include: The Action Arm Research Test (ARAT),
Apple watch activity monitors (implementing tailor-made machine learning methods to interpret
UL movement data), Barthel Index (BI), Modified Rankin Scale (mRS), Hospital Anxiety and
Depression Scale (HADS), Faces Pain Rating Scale (FPRS), Stanford Fatigue Visual Numeric
Scale (SFVNS).
Assessments administered for the purpose of sample description (sub group analysis) and
stratification will include: National Institutes of Health Stroke Scale (NIHSS), Edinburgh
Handedness Scale (EHS), Montreal Cognitive Assessment (MOCA), Likert scale participant
feedback forms (devised for the purposes of the current study). For purposively sampled
sub-groups of participants, sub studies will explore bilateral naturalistic UL activity
patterns in free living (intervention and control groups) and qualitative interviews will
examine the mechanisms of behavioral change as relevant to the intervention (intervention
group only).
Population: A convenience sample of 72 stroke survivors will be screened and consented by
delegated health care practitioners (HCPs) or researchers at participating sites (i.e
Co-Investigators (Co-Is)). Co-Is will also be invited to complete end-point feedback forms.
Eligibility: Participants will be 18yrs or over, acute/sub-acute stroke survivors with new UL
impairment, fitting inclusion criteria specified herewith.
Duration: Participants' enrolment in the study will last up to 6months. The study recruitment
phase will open for a total of 12months. The overall research period, including analysis and
write up is anticipated to last 21months.