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

Primary Purpose

Stroke

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Adapted H-GRASP feedback program

About this trial

This is an interventional treatment trial for Stroke focused on measuring upper limb, daily life activity, home-based exercise program, feedback, perceived activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

Private physiotherapy practices

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AH-GRASP feedback intervention group

Arm Description

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

Outcomes

Primary Outcome Measures

Recruitment rate

% of individuals who were eligible and agreed to participate

Retention rate

% of participants who completed the intervention

Adherence to the intervention protocol

% of participants who achieved 12 hours of average weekly exercise

Safety

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

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

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

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

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.

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.

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.

Secondary Outcome Measures

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

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

Action Research Arm Test (ARAT)

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

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

Patient-reported amount of UL use in daily life

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

Patient-reported quality of UL use in daily life

Erasmus modified Nottingham Sensory Assessment (Em-NSA)

Sensory assessment of the UL

simplified modified Rankin Scale questionnaire (smRSq)

Global disability. Minimum 0 - maximum 5; higher scores mean worse outcome.

Hospital Anxiety and Depression Scale (HADS)

Symptoms of anxiety and depression. Minimum 0 - maximum 42; higher scores mean worse outcome.

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.

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.

EuroQol Five Dimensions Five Levels Questionnaire (EQ-5D-5L)

Health-related quality of life. Minimum 0, maximum 100, higher scores mean better outcome.

Hours of UL activity

Sum of all seconds recorded when the activity count was nonzero and converted to hours

Bilateral magnitude

Intensity of the movement: sum of the vector magnitude from the two ULs

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.

Density plot

Graphical representation of accelerometry data from both ULs

Full Information

NCT ID

NCT05227521

First Posted

January 14, 2022

Last Updated

June 30, 2023

Sponsor

KU Leuven

Collaborators

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT05227521

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

January 31, 2022 (Actual)

Primary Completion Date

June 25, 2023 (Actual)

Study Completion Date

June 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

Collaborators

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AH-GRASP feedback intervention group

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Adapted H-GRASP feedback program

Intervention Description

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

Primary Outcome Measure Information:

Title

Recruitment rate

Description

% of individuals who were eligible and agreed to participate

Time Frame

45 days (post-intervention)

Title

Retention rate

Description

% of participants who completed the intervention

Time Frame

45 days (post-intervention)

Title

Adherence to the intervention protocol

Description

% of participants who achieved 12 hours of average weekly exercise

Time Frame

45 days (post-intervention)

Title

Safety

Description

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

Time Frame

45 days (post-intervention)

Title

Activity ratio

Description

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)

Title

Activity ratio

Description

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)

Title

Activity ratio

Description

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)

Title

Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)

Description

Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome.

Time Frame

Day 1 (enrolment)

Title

Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)

Description

Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome.

Time Frame

Day 17 (baseline)

Title

Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)

Description

Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome.

Time Frame

45 days (post-intervention)

Secondary Outcome Measure Information:

Title

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

Description

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)

Title

Action Research Arm Test (ARAT)

Description

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

Time Frame