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

NCT05227521 | Completed Phase 1

• 2 other identifiers: S661231153320N
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

upper limb; daily life activity; home-based exercise program; feedback; perceived activity

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (14)

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

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

• Action Research Arm Test (ARAT)

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

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

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

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

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

• Erasmus modified Nottingham Sensory Assessment (Em-NSA)

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

Other Outcomes (7)

• Demographics

  Day 1 (enrolment)

• Stroke event data

  Day 1 (enrolment)

• National Institutes of Health Stroke Scale (NIHSS)

  Day 1 (enrolment)

Study Arms (1)

AH-GRASP feedback intervention group

EXPERIMENTAL

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

Behavioral: Adapted H-GRASP feedback program

Interventions

Adapted H-GRASP feedback program BEHAVIORAL

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

AH-GRASP feedback intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

Private physiotherapy practices

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Geert Verheyden, Professor

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 7, 2022
• Study Start: January 31, 2022
• Primary Completion: June 25, 2023
• Study Completion: June 25, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)