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

KU Leuven19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Adapted H-GRASP feedback programBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Private physiotherapy practices

Leuven, Belgium

Outcomes

Primary Outcomes

Recruitment rate

% of individuals who were eligible and agreed to participate

Time frame: 45 days (post-intervention)

Retention rate

% of participants who completed the intervention

Time frame: 45 days (post-intervention)

Adherence to the intervention protocol

% of participants who achieved 12 hours of average weekly exercise

Time frame: 45 days (post-intervention)

Safety

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

Time frame: 45 days (post-intervention)

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

Time frame: Day 1 (enrolment)

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

Time frame: Day 17 (baseline)

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

Time frame: 45 days (post-intervention)

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.

Time frame: Day 1 (enrolment)

Data from ClinicalTrials.gov

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Secondary Outcomes

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

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

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

Action Research Arm Test (ARAT)

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