Clinical trial NCT05227521: Feasibility of the Adapted H-GRASP Feedback Program in the Chronic Phase Post Stroke.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: upper limb
daily life activity
home-based exercise program
feedback
perceived activity
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2022-02-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 45 days (post-intervention)
measure: Retention rate
timeFrame: 45 days (post-intervention)
measure: Adherence to the intervention protocol
timeFrame: 45 days (post-intervention)
measure: Safety
timeFrame: 45 days (post-intervention)
measure: Activity ratio
timeFrame: Day 1 (enrolment)
measure: Activity ratio
timeFrame: Day 17 (baseline)
measure: Activity ratio
timeFrame: 45 days (post-intervention)
measure: Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)
timeFrame: Day 1 (enrolment)
measure: Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)
timeFrame: Day 17 (baseline)
measure: Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)
timeFrame: 45 days (post-intervention)
Secondary outcomes:
measure: Fugl-Meyer motor assessment - upper extremity (FMA-UE)
timeFrame: Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)
measure: Action Research Arm Test (ARAT)
timeFrame: Day 17 (baseline), 45 days (post-intervention)
measure: Motor Activity Log - 14 Item Version Amount Of Use (MAL-14 AOU)
timeFrame: Day 17 (baseline), 45 days (post-intervention)
measure: Motor Activity Log - 14 Item Version Quality Of Movement (MAL-14 QOM)
timeFrame: Day 17 (baseline), 45 days (post-intervention)
measure: Erasmus modified Nottingham Sensory Assessment (Em-NSA)
timeFrame: Day 17 (baseline), 45 days (post-intervention)
measure: simplified modified Rankin Scale questionnaire (smRSq)
timeFrame: Day 17 (baseline), 45 days (post-intervention)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 17 (baseline), 45 days (post-intervention)
measure: Confidence in Arm and Hand Movement Scale (CAHM)
timeFrame: Day 17 (baseline), 45 days (post-intervention)
measure: Visual Analogue Scale (VAS)
timeFrame: Day 17 (baseline), 45 days (post-intervention)
measure: EuroQol Five Dimensions Five Levels Questionnaire (EQ-5D-5L)
timeFrame: Day 17 (baseline), 45 days (post-intervention)
measure: Hours of UL activity
timeFrame: Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)
measure: Bilateral magnitude
timeFrame: Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)
measure: Magnitude ratio
timeFrame: Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)
measure: Density plot
timeFrame: Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)
Other outcomes:
measure: Demographics
timeFrame: Day 1 (enrolment)
measure: Stroke event data
timeFrame: Day 1 (enrolment)
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Day 1 (enrolment)
measure: Edinburgh Handedness Inventory (EHI)
timeFrame: Day 1 (enrolment)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Day 1 (enrolment)
measure: Apples Test
timeFrame: Day 1 (enrolment)
measure: Barthel Index (BI)
timeFrame: Day 1 (enrolment)
Locations:
city: Leuven
country: Belgium
facility: Private physiotherapy practices
Study officials:
affiliation: KU Leuven
name: Geert Verheyden, Professor
role: PRINCIPAL_INVESTIGATOR
References: