StrokeSAGENCT04475692
Self-directed Adapted Gaming Exercises for Stroke Survivors
A study testing Repetitive, task-specific upper limb practice and Conventional care in people with Stroke and Cerebrovascular Accident, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accident
- What is being tested?
- Repetitive, task-specific upper limb practice and Conventional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Pilot Randomised Control Trial of an Adapted Mobile Rehabilitation System for Self-directed Rehabilitation and Improved Upper Limb Outcomes in Stroke Survivors With Upper Limb Weakness
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.
Read the detailed 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.
- Conditions
- Stroke, Cerebrovascular Accident
- Being tested
- Repetitive, task-specific upper limb practice, Conventional care
- Keywords
- Rehabilitation, Upper limb, Technology, Self-administered, Self-directed
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive, task-specific upper limb practiceBehavioural
Also called Gamified exercise, Interactive gaming, Virtual reality, Self-directed upper limb rehabilitation
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.
Conventional careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The ARAT is an UL capacity test which assesses the ability to grasp, move and release objects of various sizes, weights and shapes. It has 19 sub questions scored on a 4-point ordinal scale, adding up to a total score between 0 and 57 points (57 = normal capacity).
Measured: Change between scores from baseline (0-1month post stroke) to 3months post stroke and 6months post stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Nov 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton
- Responsible party
- Sponsor
- Investigators
- Jane Burridge, Study chair, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475692
- Sponsor's protocol ID
- 20CX5959
- Acronym
- SAGE
- Status last verified
- Oct 2023
- First submitted
- 9 Jul 2020
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be used for the specified purposes only. Data will not be shared outside of the primary research team.
Publications
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.
PubMed 38245014
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Pilot Randomised Control Trial of an Adapted Mobile Rehabilitation System for Self-directed Rehabilitation and Improved Upper Limb Outcomes in Stroke Survivors With Upper Limb Weakness
- ClinicalTrials.gov ID
- NCT04475692
- Acronym / sponsor ID
- SAGE / 20CX5959
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- Rehabilitation, Upper limb, Technology, Self-administered, Self-directed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Southampton
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Repetitive, task-specific upper limb practice, Other: Conventional careConventional 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. |
| Control | Active comparator | Other: Conventional careBaseline 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive, task-specific upper limb practiceAlso: Gamified exercise, Interactive gaming, Virtual reality, Self-directed upper limb rehabilitationA 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. | Behavioural | Intervention |
| Conventional careConventional 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. | Other | Control, Intervention |
Primary outcome
Fugl-Meyer Assessment- Upper Extremity (FM-UE)
Time frame: Change between scores from baseline (0-1month post stroke) to 3months post stroke and 6months post stroke
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.
1 secondary outcome
Action Research Arm Test (ARAT)
Time frame: Change between scores from baseline (0-1month post stroke) to 3months post stroke and 6months post stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 38245014Broderick 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.
- Individual participant dataSharing planned: No. Data will be used for the specified purposes only. Data will not be shared outside of the primary research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Burridge study chair
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive, task-specific upper limb practice and Conventional care in people with Stroke and Cerebrovascular Accident, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment- Upper Extremity (FM-UE) (time frame: Change between scores from baseline (0-1month post stroke) to 3months post stroke and 6months post stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023; AzTrials last refreshed its copy on 29 Oct 2026.