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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Adapted H-GRASP feedback program

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Private physiotherapy practices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AH-GRASP feedback intervention group; All study participants will receive the AH-GRASP feedback intervention.	Behavioral: Adapted H-GRASP feedback program; Combination of the Home-Graded Repetitive Arm Supplementary Program with in home accelerometer-based feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	% of individuals who were eligible and agreed to participate	45 days (post-intervention)
Retention rate	% of participants who completed the intervention	45 days (post-intervention)
Adherence to the intervention protocol	% of participants who achieved 12 hours of average weekly exercise	45 days (post-intervention)
Safety	# of participants with increased pain while performing exercises as measured by visual analogue scale	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	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	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	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.	Day 1 (enrolment)
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.	Day 17 (baseline)
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.	45 days (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer motor assessment - upper extremity (FMA-UE)	Observed motor function of the affected UL (shoulder, arm, wrist, hand, and fingers)	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	Day 17 (baseline), 45 days (post-intervention)
Motor Activity Log - 14 Item Version Amount Of Use (MAL-14 AOU)	Patient-reported amount of UL use in daily life	Day 17 (baseline), 45 days (post-intervention)
Motor Activity Log - 14 Item Version Quality Of Movement (MAL-14 QOM)	Patient-reported quality of UL use in daily life	Day 17 (baseline), 45 days (post-intervention)
Erasmus modified Nottingham Sensory Assessment (Em-NSA)	Sensory assessment of the UL	Day 17 (baseline), 45 days (post-intervention)
simplified modified Rankin Scale questionnaire (smRSq)	Global disability. Minimum 0 - maximum 5; higher scores mean worse outcome.	Day 17 (baseline), 45 days (post-intervention)
Hospital Anxiety and Depression Scale (HADS)	Symptoms of anxiety and depression. Minimum 0 - maximum 42; higher scores mean worse outcome.	Day 17 (baseline), 45 days (post-intervention)
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.	Day 17 (baseline), 45 days (post-intervention)
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.	Day 17 (baseline), 45 days (post-intervention)
EuroQol Five Dimensions Five Levels Questionnaire (EQ-5D-5L)	Health-related quality of life. Minimum 0, maximum 100, higher scores mean better outcome.	Day 17 (baseline), 45 days (post-intervention)
Hours of UL activity	Sum of all seconds recorded when the activity count was nonzero and converted to hours	Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)
Bilateral magnitude	Intensity of the movement: sum of the vector magnitude from the two ULs	Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)
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.	Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)
Density plot	Graphical representation of accelerometry data from both ULs	Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Participant demography	Day 1 (enrolment)
Stroke event data	Disease characteristics	Day 1 (enrolment)
National Institutes of Health Stroke Scale (NIHSS)	Neurological impairments. Minimum 0, maximum 42, higher scores mean worse outcome.	Day 1 (enrolment)
Edinburgh Handedness Inventory (EHI)	Handedness	Day 1 (enrolment)
Montreal Cognitive Assessment (MoCA)	Cognitive function	Day 1 (enrolment)
Apples Test	Visuospatial neglect	Day 1 (enrolment)
Barthel Index (BI)	Performance in activities of daily living	Day 1 (enrolment)

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Geert Verheyden, Professor, KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): June 25, 2023
• Study Completion (Actual): June 25, 2023

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: upper limb; feedback; daily life activity; home-based exercise program; perceived activity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: S66123; 1153320N (Other Grant/Funding Number: Research Foundation - Flanders (FWO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes