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Completed

NCT Number: NCT05227521

Feasibility of the Adapted H-GRASP Feedback Program in the Chronic Phase Post Stroke.

In a recent cross-sectional study, it was shown that people with a good observed upper limb (UL) motor function but low perceived UL activity show a reduced daily-life UL activity. The investigators will now investigate the feasibility of a phone-monitored home exercise and feedback program for the UL following stroke and the preliminary effects on the perceived UL activity and actual daily-life UL activity for participants with good observed UL motor function but low perceived UL activity in the chronic phase post-stroke.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Private physiotherapy practices

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary written informed consent of the participant has been obtained prior to any screening procedures
  • First-ever unilateral, supratentorial stroke, as defined by the American Heart Association/American Stroke Association
  • Minimum six months after stroke
  • Living in the community
  • ≥18 years old
  • Good observed UL motor function but low perceived UL activity. Good observed UL motor function is defined as a score >50/66 on the Fugl-Meyer Assessment-Upper Extremity (FMA-UE). Low perceived UL activity is defined as a score ≤75/100 on the hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand).

Exclusion criteria

  • Other neurological condition than stroke
  • Musculoskeletal disorder that affects UL use
  • No informed consent
  • Participation in an interventional Study with an investigational medicinal product (IMP) or device

Treatment and study plan

Adapted H-GRASP feedback program

Behavioral

Combination of the Home-Graded Repetitive Arm Supplementary Program with in home accelerometer-based feedback

Primary outcomes

  1. Recruitment rate

    Time frame: 45 days (post-intervention)

    % of individuals who were eligible and agreed to participate

  2. Retention rate

    Time frame: 45 days (post-intervention)

    % of participants who completed the intervention

  3. Adherence to the intervention protocol

    Time frame: 45 days (post-intervention)

    % of participants who achieved 12 hours of average weekly exercise

  4. Safety

    Time frame: 45 days (post-intervention)

    # of participants with increased pain while performing exercises as measured by visual analogue scale

  5. Activity ratio

    Time frame: Day 1 (enrolment)

    Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL

  6. Activity ratio

    Time frame: Day 17 (baseline)

    Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL

  7. Activity ratio

    Time frame: 45 days (post-intervention)

    Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL

  8. Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)

    Time frame: Day 1 (enrolment)

    Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome.

  9. Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)

    Time frame: Day 17 (baseline)

    Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome.

  10. Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)

    Time frame: 45 days (post-intervention)

    Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome.

Secondary outcomes

  1. Fugl-Meyer motor assessment - upper extremity (FMA-UE)

    Time frame: Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)

    Observed motor function of the affected UL (shoulder, arm, wrist, hand, and fingers)

  2. Action Research Arm Test (ARAT)

    Time frame: Day 17 (baseline), 45 days (post-intervention)

    Grasp, grip, pinch and gross movement of the affected UL

  3. Motor Activity Log - 14 Item Version Amount Of Use (MAL-14 AOU)

    Time frame: Day 17 (baseline), 45 days (post-intervention)

    Patient-reported amount of UL use in daily life

  4. Motor Activity Log - 14 Item Version Quality Of Movement (MAL-14 QOM)

    Time frame: Day 17 (baseline), 45 days (post-intervention)

    Patient-reported quality of UL use in daily life

  5. Erasmus modified Nottingham Sensory Assessment (Em-NSA)

    Time frame: Day 17 (baseline), 45 days (post-intervention)

    Sensory assessment of the UL

  6. simplified modified Rankin Scale questionnaire (smRSq)

    Time frame: Day 17 (baseline), 45 days (post-intervention)

    Global disability. Minimum 0 - maximum 5; higher scores mean worse outcome.

  7. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Day 17 (baseline), 45 days (post-intervention)

    Symptoms of anxiety and depression. Minimum 0 - maximum 42; higher scores mean worse outcome.

  8. Confidence in Arm and Hand Movement Scale (CAHM)

    Time frame: Day 17 (baseline), 45 days (post-intervention)

    Perceived self-efficacy in performing tasks with the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome.

  9. Visual Analogue Scale (VAS)

    Time frame: Day 17 (baseline), 45 days (post-intervention)

    Pain intensity in the affected UL from 0 (no pain) to 10 (extreme). Minimum 0, maximum 10, higher scores mean worse outcome.

  10. EuroQol Five Dimensions Five Levels Questionnaire (EQ-5D-5L)

    Time frame: Day 17 (baseline), 45 days (post-intervention)

    Health-related quality of life. Minimum 0, maximum 100, higher scores mean better outcome.

  11. Hours of UL activity

    Time frame: Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)

    Sum of all seconds recorded when the activity count was nonzero and converted to hours

  12. Bilateral magnitude

    Time frame: Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)

    Intensity of the movement: sum of the vector magnitude from the two ULs

  13. Magnitude ratio

    Time frame: Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)

    Contribution to the activity of one limb versus the other: natural log of the vector magnitude of the affected UL divided by the vector magnitude of the unaffected UL, whereby values greater than and less than -7 were replaced by 7 and -7, respectively, to categorize single limb movement.

  14. Density plot

    Time frame: Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)

    Graphical representation of accelerometry data from both ULs

Other outcomes

  1. Demographics

    Time frame: Day 1 (enrolment)

    Participant demography

  2. Stroke event data

    Time frame: Day 1 (enrolment)

    Disease characteristics

  3. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: Day 1 (enrolment)

    Neurological impairments. Minimum 0, maximum 42, higher scores mean worse outcome.

  4. Edinburgh Handedness Inventory (EHI)

    Time frame: Day 1 (enrolment)

    Handedness

  5. Montreal Cognitive Assessment (MoCA)

    Time frame: Day 1 (enrolment)

    Cognitive function

  6. Apples Test

    Time frame: Day 1 (enrolment)

    Visuospatial neglect

  7. Barthel Index (BI)

    Time frame: Day 1 (enrolment)

    Performance in activities of daily living

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

The Feasibility of the Adapted H-GRASP Feedback Program for Perceived and Daily Life UL Activity in Patients With Good Observed But Low Perceived Activity in the Chronic Phase Post Stroke: a Pilot Study.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2022
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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