EvolvRehab for Telerehabilitation

NCT05875792 | Completed

• 1 other identifier: SBRIH18P2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study includes two stages to develop the use of EvolvRehab telerehabilitation in the use of Stroke patients, early after stroke. All tasks will be conducted by multiple research sites. Stage 2 will include at least 6 weeks of study intervention, and up to 6 months follow-up, where possible.

Conditions

Stroke

Keywords

telerehabilitation; rehabilitation; stroke

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Assessment

  The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total: Movements are scored between 0 (none), 1 (partial) or 2 (full/ can be elicited) for reflex activity, volitional movement within synergies, volitional movement mixing synergies, volitional movement with little or no synergy, for upper body including wrist and hand. Normal reflex activity is scored 0 (hyper), 1 (lively) or 2 (normal). Co-ordination is scored 0 (marked), 1 (slight) or 2 (none). Sensation is scored 0 (anesthesia), 1 (hypoesthesia or dysesthesia), 2 (normal) Joint motion is scored 0 (only few degrees), 1 (decreased), 2 (normal) Joint pain is scored 0 (pronounced pain), 1 (some pain), 2 (no pain)

  6 weeks

Secondary Outcomes (14)

• Carer Strain Index (CSI)

  6 weeks

• Grip strength

  6 weeks

• European Quality of Life questionnaire (Eq-5D-5L)

  6 weeks

• The World Health Organization Disability Assessment Schedule (WHODAS)

  6 weeks

• Health resource use questionnaire

  6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

people who have recently had a stroke and need upper limb rehabilitation

Device: EvolvRehab - MoveWell

Interventions

EvolvRehab - MoveWell DEVICE

The Intervention has been developed and has a CE mark and has medical device level 1 approvals in the UK. It will be developed with patients in Phase 1 and will consist of initial staff training \[training package\]. Exercise prescription will be encouraged, in line with usual care, for the either one week (stage 1, phase 2) or six weeks (stage 2, phase 2). Individuals will be able to continue using the EvolvRehab - MoveWell system beyond 6 weeks from stage 2, phase 2, and technical support will continue until the end of the study completion, participants will not be limited in the additional activity that can be performed during this time, and encouraged to do as much as they wish, except if needed for clinical reasons. The intervention will be supported by the clinical team in keeping with routine care. The research therapist will attend clinical visits and support as required. The number of visits will be recorded, and will hopefully reduce to zero over the study.

Intervention

Eligibility Criteria

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

You may qualify if:

• Experiencing motor difficulties in using the paretic arm, with some use of hand/arm as determined by clinical treatment team
• Able to safely participate and complete EvolvRehab activities as determined by clinical treatment team
• Male/female ≥18 years old
• Recently had a stroke requiring upper limb intensive rehabilitation
• The participant is expected to be able to use equipment for a minimum of 1 week
• Capacity to consent to participate
• Able to communicate adequately in English with the research team

You may not qualify if:

• Participating in another intervention which the research team deem could interfere with study outcomes
• Any medical condition compromising the safety or the ability to take part to the study as determined by the clinical treatment team (such as insufficient vision or hearing, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)
• History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure
• Cognitive or communication impairment such that the participant is unable to follow a two stage command
• Moderate to severe hemi-spatial neglect compromising the ability to take part to the study, as determined by research team

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

Royal Devon and Exeter Hospitals

Exeter, United Kingdom

Location

Related Publications (1)

• Perks J, McBride P, Mansoubi M, Clatworthy P, Hulme C, Taylor G, Warner M, Dawes H. EvolvRehab-MoveWell telerehabilitation for stroke survivors: study protocol for a feasibility with embedded initial proof-of-concept study. BMJ Open. 2024 May 6;14(5):e078104. doi: 10.1136/bmjopen-2023-078104.

  PMID: 38719328 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Single arm, before and after feasability study

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: May 25, 2023
• Study Start: June 14, 2023
• Primary Completion: May 4, 2024
• Study Completion: May 4, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

GB (1)