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

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227521
• Other study ID #: S66123
• Secondary ID: 1153320N
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 31, 2022
• Est. completion date: June 25, 2023

Study information

• Verified date: June 2023
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 25, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Adapted H-GRASP feedback program
Combination of the Home-Graded Repetitive Arm Supplementary Program with in home accelerometer-based feedback

Locations

Country	Name	City	State
Belgium	Private physiotherapy practices	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Participant demography	Day 1 (enrolment)
Other	Stroke event data	Disease characteristics	Day 1 (enrolment)
Other	National Institutes of Health Stroke Scale (NIHSS)	Neurological impairments. Minimum 0, maximum 42, higher scores mean worse outcome.	Day 1 (enrolment)
Other	Edinburgh Handedness Inventory (EHI)	Handedness	Day 1 (enrolment)
Other	Montreal Cognitive Assessment (MoCA)	Cognitive function	Day 1 (enrolment)
Other	Apples Test	Visuospatial neglect	Day 1 (enrolment)
Other	Barthel Index (BI)	Performance in activities of daily living	Day 1 (enrolment)
Primary	Recruitment rate	% of individuals who were eligible and agreed to participate	45 days (post-intervention)
Primary	Retention rate	% of participants who completed the intervention	45 days (post-intervention)
Primary	Adherence to the intervention protocol	% of participants who achieved 12 hours of average weekly exercise	45 days (post-intervention)
Primary	Safety	# of participants with increased pain while performing exercises as measured by visual analogue scale	45 days (post-intervention)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	Action Research Arm Test (ARAT)	Grasp, grip, pinch and gross movement of the affected UL	Day 17 (baseline), 45 days (post-intervention)
Secondary	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)
Secondary	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)
Secondary	Erasmus modified Nottingham Sensory Assessment (Em-NSA)	Sensory assessment of the UL	Day 17 (baseline), 45 days (post-intervention)
Secondary	simplified modified Rankin Scale questionnaire (smRSq)	Global disability. Minimum 0 - maximum 5; higher scores mean worse outcome.	Day 17 (baseline), 45 days (post-intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Density plot	Graphical representation of accelerometry data from both ULs	Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention)