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StrokePhase 1/2NCT05227521

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

A Phase 1/2 study testing Adapted H-GRASP feedback program in people with Stroke, run by KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Adapted H-GRASP feedback program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteBelgium
Study dates
31 Jan 2022to 25 Jun 2023
Phase
Phase 1/2
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

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Private physiotherapy practices

    Leuven, 3000

Other trials in Belgium

About this study

Official 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.

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.

Conditions
Stroke
Being tested
Adapted H-GRASP feedback program
Keywords
upper limb, daily life activity, home-based exercise program, feedback, perceived activity
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted H-GRASP feedback programBehavioural

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

Study groups in NCT05227521
Study groupRoleWhat they receive
AH-GRASP feedback intervention groupExperimentalAll study participants will receive the AH-GRASP feedback intervention.
Receives: Behavioral: Adapted H-GRASP feedback program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    % of individuals who were eligible and agreed to participate

    Measured: 45 days (post-intervention)

  2. Retention rate

    % of participants who completed the intervention

    Measured: 45 days (post-intervention)

  3. Adherence to the intervention protocol

    % of participants who achieved 12 hours of average weekly exercise

    Measured: 45 days (post-intervention)

  4. Safety

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

    Measured: 45 days (post-intervention)

  5. Activity ratio

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

    Measured: Day 1 (enrolment)

  6. Activity ratio

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

    Measured: Day 17 (baseline)

  7. Activity ratio

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

    Measured: 45 days (post-intervention)

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

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

    Measured: Day 1 (enrolment)

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

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

    Measured: Day 17 (baseline)

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

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

    Measured: 45 days (post-intervention)

Secondary outcomes (14)

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

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

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

  2. Action Research Arm Test (ARAT)

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

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

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

    Patient-reported amount of UL use in daily life

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

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

    Patient-reported quality of UL use in daily life

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

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

    Sensory assessment of the UL

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

  6. simplified modified Rankin Scale questionnaire (smRSq)

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

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

  7. Hospital Anxiety and Depression Scale (HADS)

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

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

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

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

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

  9. Visual Analogue Scale (VAS)

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

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

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

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

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

  11. Hours of UL activity

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

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

  12. Bilateral magnitude

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

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

  13. Magnitude ratio

    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.

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

  14. Density plot

    Graphical representation of accelerometry data from both ULs

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start31 Jan 2022
  3. Primary completion25 Jun 2023
  4. Study completion25 Jun 2023

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05227521
Sponsor's protocol ID
S66123
Other IDs
1153320N
Status last verified
Jun 2023
First submitted
14 Jan 2022
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Essers B, Veerbeek JM, Luft AR, Verheyden G. The feasibility of the adapted H-GRASP program for perceived and actual daily-life upper limb activity in the chronic phase post-stroke. Disabil Rehabil. 2024 Dec;46(24):5815-5828. doi: 10.1080/09638288.2024.2313121. Epub 2024 Feb 8.

    PubMed 38329448

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Adapted H-GRASP feedback program in people with Stroke, run by KU Leuven at 1 site in Belgium.

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 6 inclusion and 4 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 3 Jul 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 Belgium. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Recruitment rate (time frame: 45 days (post-intervention)). The study lists 10 primary outcomes in all. 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 NCT05227521, 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 3 Jul 2023.

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