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

NCT ID: NCT05227521

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2023-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AH-GRASP feedback intervention group

All study participants will receive the AH-GRASP feedback intervention.

Group Type EXPERIMENTAL

Adapted H-GRASP feedback program

Intervention Type BEHAVIORAL

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

Interventions

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Adapted H-GRASP feedback program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures
2. First-ever unilateral, supratentorial stroke, as defined by the American Heart Association/American Stroke Association
3. Minimum six months after stroke
4. Living in the community
5. ≥18 years old
6. 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

1. Other neurological condition than stroke
2. Musculoskeletal disorder that affects UL use
3. No informed consent
4. Participation in an interventional Study with an investigational medicinal product (IMP) or device
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Prof Geert Verheyden

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geert Verheyden, Professor

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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Private physiotherapy practices

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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1153320N

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S66123

Identifier Type: -

Identifier Source: org_study_id

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