Self-directed Adapted Gaming Exercises for Stroke Survivors

NCT04475692 | Completed DMC

• 1 other identifier: 20CX5959
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Cerebrovascular Accident

Keywords

Rehabilitation; Upper limb; Technology; Self-administered; Self-directed

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment- Upper Extremity (FM-UE)

  Upper limb (UL) impairment-based measure: The FM-UE assesses UL impairment in terms of synergistic motor control. It has 3 categories, comprised of 22 sub questions scored on a 3-point ordinal scale (0=unable, 1=partial, 2=near normal). The sum of the categories ranges between 0 and 66 points (66 = normal function). The FM-UE has shown excellent inter-rater reliability (Sullivan et al., 2011)(Duncan, Goldstein, Matchar, Divine, \& Feussner, 1992) moderate to good responsiveness (Lundquist \& Maribo, 2017) and good concurrent validity when compared with similar tests of arm motor functioning.

  Change between scores from baseline (0-1month post stroke) to 3months post stroke and 6months post stroke

Secondary Outcomes (1)

• Action Research Arm Test (ARAT)

  Change between scores from baseline (0-1month post stroke) to 3months post stroke and 6months post stroke

Study Arms (2)

Intervention

EXPERIMENTAL

Conventional care will continue. Participants (and proxy, where relevant) will be trained to use the intervention platform (GripAble). Participants will be loaned a GripAble device and advised to continue a self-selected training dose throughout the intervention period. Weekly follow-up phone calls will be conducted, remote tech support will be available. Adherence with the intervention will be remotely monitored via an inbuilt data capture system. At 3months post stroke, the intervention period will conclude, outcome measures will be implemented. Participants will be invited to complete a post intervention survey and interview. A purposive sample of participants will be invited to participate in an UL activity monitoring sub-study. At 6months post stroke, follow-up outcome measures will be implemented. Participants will be invited to take part in a research implementation feedback survey.

Behavioral: Repetitive, task-specific upper limb practice; Other: Conventional care

Control

ACTIVE COMPARATOR

Baseline data collection and outcome measures will be completed. Conventional care will continue, no restrictions/specifications will be placed on this. At 3months post stroke, UL outcome measures will be implemented. A purposive sample of participants will be invited to participate in an UL activity monitoring sub-study. At 6months post stroke, follow-up UL outcome measures will be implemented. Participants will be invited to take part in a research implementation feedback survey.

Other: Conventional care

Interventions

Repetitive, task-specific upper limb practice BEHAVIORAL

A self-directed upper limb intervention (implementing a self-selected dose). This intervention uses an adapted upper limb rehabilitation system to support repetitive upper limb training for stroke survivors.

Also known as: Gamified exercise, Interactive gaming, Virtual reality, Self-directed upper limb rehabilitation

Intervention

Conventional care OTHER

Conventional care is the standard care offered to stroke patients in their respective settings. In this context it is guided by Royal College of Physicians (2016). For the purposes of this work, conventional care encompasses any rehabilitation or support services accessed by participants within the primary or secondary care setting, including private therapy services, charity-led exercise groups etc. Conventional care will not be specified in the context of this work, as it is complex in nature and varies between settings.

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• Cognitive status that would permit for use /supported use of intervention device and engagement in protocol related trainings/assessment. To be indicated by treating clinician at point of screening, formal capacity assessment to be conducted as/if appropriate. Easy read patient information sheet (PIS) and training materials will be implemented to support patients presenting with specific cognitive and/or communication needs.
• Stroke diagnosis (can be first or subsequent stroke, unilateral haemorrhagic or ischemic) 4 weeks max post stroke at time of recruitment.
• Can communicate in English, that is, sufficient for completion of intervention and outcome measures. It is advisable that a decision to include or exclude those with significant expressive or receptive communication impairment should be made following consultation with the treating speech and language therapist (SLT) to ensure all reasonable accommodations are made to support participation.
• UL motor deficit post stroke (bilateral/unilateral) (according to National Institutes of Health Stroke Score (NIHSS) item 5), distal UL power \>1 /5 on the Oxford Rating Scale (Medical Research Council Manual Muscle Testing scale) or voluntary finger extension of the thumb and/or two or more fingers of the affected hand (to 10° or more). The presence of sensory impairment (including neglect syndrome) or movement disorder (apraxia) is not a contraindication to enrolment as long as there is a concurrent motor deficit (as described above).

You may not qualify if:

• Patients already enrolled an interventional neuro rehabilitation trial.
• Patients enrolled in clinical trials that contraindicate co-enrolment.
• Patients presenting with unstable medical conditions/medical contraindications as determined by treating medical consultant (these patients may be approached at a later date should their condition improve).
• Patients with uncontrolled photosensitive epilepsy/Other neurological symptoms that may be exacerbated by required focus on light emitting diode (LED) screen/moving object on screen).
• Those registered blind/with uncompensated/uncorrected visual deficits.
• Behavioural/affective dysfunction which could influence the ability of the person to engage with the research protocol and/or pose risk to the participating researchers (in circumstances such as follow-up community visits).
• Other concomitant neurological disorders affecting upper extremity motor function (Multiple Sclerosis, Spinal Cord Injury, Brachial Plexus or Radial Nerve Injury).
• Unremitting arm pain at rest.
• Pre-existing UL impairment with known and significant disruption to range of motion, motor or functional performance (fracture, arthritic changes, other known musculoskeletal problems).
• Skin condition apparent on the ventral UE such that might place participant at risk of irritation in the context of repeated physical contact (such as that associated with the intervention).

Sponsors & Collaborators

• Imperial College London: lead
• University of Southampton: collaborator

Study Sites (1)

Paul Bentley

London, W6 8RF, United Kingdom

Location

Related Publications (1)

• Broderick M, Burridge J, Demain S, Johnson L, Brereton J, O'Shea R, Bentley P. Multicentre pilot randomised control trial of a self-directed exergaming intervention for poststroke upper limb rehabilitation: research protocol. BMJ Open. 2024 Jan 19;14(1):e077121. doi: 10.1136/bmjopen-2023-077121.

  PMID: 38245014 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jane Burridge

  University of Southampton

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This will be an assessor-blinded protocol, due to the nature of the intervention, participants cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 17, 2020
• Study Start: November 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)