What do I Think I Can do and What do I Really do: the Use of the Arm in Daily Life After Stroke

Investigating the Actual Daily-life Upper Limb Activity Profile in Relation to Observed and Perceived Function in the Chronic Phase Post Stroke

This study was organized to investigate the real upper limb use in persons after stroke. Persons after stroke often have problems moving their affected arm, leading to limitations in performing simple tasks. In previous research in a group of 60 patients post stroke the investigators investigated two things: they observed how patients can move their affected arm, and the investigators asked patients to indicate how they think they can use their affected arm. Surprisingly, the investigators concluded that in patients with a similar, good observed arm use there were two groups: (1) a 'match' group, reporting they can use their arm well, and (2) a 'mismatch' group, reporting they can not use their arm well. This project will further investigate this last group. The investigators will now use sensor technology to investigate the actual daily life arm use during daily life. The investigators hypothesize this daily arm use will be lower in the mismatch group than in the group with good observed and perceived ability.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: "Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer

Detailed Description

The investigators will perform a cross-sectional study to acquire insight into the actual daily-life UL activity profile of patients in the chronic phase post stroke. A sample of 60 community-dwelling patients more than six months after stroke will be recruited and will be investigated with both standardized clinical, patient-reported and sensor-based UL assessments. Our sample will include three groups of 20 patients with (1) both low observed and perceived function; (2) both good observed and perceived function; and (3) good observed but low perceived function, i.e. the mismatch group.

To better understand this mismatch group, it is pivotal to investigate daily arm and hand use in patients in the chronic phase after stroke as the investigators expect patients in the mismatch group to have significantly reduced arm and hand use throughout the day. After all, stroke rehabilitation interventions intend to improve patients' performance in daily life, but the objective evaluation of this aim is a challenge. Standardized assessments performed in the rehabilitation environment or patients' home do not validly reflect daily-life upper-limb use. To achieve insight into the observed upper limb function, apart from using internationally accepted observation-based assessments such as the FMA and SIS hand function, monitoring patients after stroke will also be performed using sensor-based systems.

The investigators hypothesize the mismatch group will show a comparable daily-life UL activity profile compared to patients with both low observed and perceived function. However, when compared to patients with good observed and perceived function, the mismatch group shows significantly reduced daily-life UL activity by means of sensor-based evaluation.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3001
    • UZ Leuven

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Sixty patients with chronic stroke (>6 months post stroke) will be recruited

Description

Inclusion Criteria:

(1) unilateral, supratentorial stroke as defined by WHO; (2) minimum 6 months after stroke, and living in the community; (3) ≥ 18 years old; and (4) informed consent.

Exclusion Criteria:

(1) a musculoskeletal and/or other neurological disorder such as previous stroke, head injury, or Parkinson's disease that interfere with the protocol; and (2) severe communication or cognitive deficits.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low match; A group with both low observed and perceived upper limb ability.	Other: "Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer; Accelerometers on both patients' wrists will give insight into the daily life upper limb use.
Good match; A group with both good observed and perceived upper limb ability.	Other: "Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer; Accelerometers on both patients' wrists will give insight into the daily life upper limb use.
Mismatch; A group with good observed but low perceived function.	Other: "Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer; Accelerometers on both patients' wrists will give insight into the daily life upper limb use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer motor assessment - upper extremity	Investigation of overall motor impairment of the affected upper limb: shoulder, arm, wrist, hand and fingers. Minimum: 0. Maximum: 66. Higher scores mean a better outcome.	After inclusion
Stroke Impact Scale 3.0	Self-reported outcome, measuring the impact of a stroke on activities, participation and quality of life, using the most affected body side. Minimum: 0. Maximum: 100, for each of the 9 domains assessed. Higher scores mean a better outcome.	After inclusion
Hours of use of each limb	Hours of use of each limb as measured with the accelerometer	After 3 days of sensor-based assessment
Use ratio	Dividing hours of use of the affected limb by the hours of use of the non-affected limb	After 3 days of sensor-based assessment
Magnitude ratio	The natural log of the vector magnitude of the non-dominant limb (or affected limb) divided by the vector magnitude of the dominant (or non-affected) limb The natural log of the vector magnitude of the non-dominant limb (or affected limb) divided by the vector magnitude of the dominant (or non-affected) limb Natural log of the vector magnitude of the affected divided by the non-affected limb	After 3 days of sensor-based assessment
Bilateral magnitude	Sum of the vector magnitude from the two limbs	After 3 days of sensor-based assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale (NIHSS)	Stroke severity. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.	After inclusion
Modified Rankin Scale (mRS)	Disability. Minimum: 0. Maximum: 42. Higher scores mean worse outcome. Minimum: 0. Maximum: 6. Higher scores mean worse outcome.	After inclusion
Montreal Cognitive Assessment (MoCA)	Cognitive impairment. Minimum: 0. Maximum: 30. Higher scores mean better outcome.	After inclusion
Start Cancellation Test (SCT)	Unilateral spatial neglect. Min: 0. Max: 54. Higher scores are better, scores <44 indicate the presence of USN.	After inclusion
Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.	After inclusion
Barthel Index (BI)	Independence in activities of daily living. Minimum: 0. Maximum: 100. Higher scores mean better outcome.	After inclusion
Functional Ambulation Categories (FAC)	Walking ability. Minimum: 0. Maximum: 5. Higher scores mean better outcome.	After inclusion
International Physical Activity Questionnaire (IPAQ)	Patient-reported physical activity. 3 levels, higher levels are better.	After inclusion
Motor Activity Log Amount of Use (MAL AOU) - Dutch version	Amount the individual uses the paretic arm. 26 items, per item: min. 0, max. 5. Higher scores mean better outcome.	After inclusion
ABILHAND	Self-reported measure of (bi)manual ability in everyday activities. Rasch based logit scale. Higher logit scores mean better outcome.	After inclusion

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Research Foundation Flanders
• Investigators: Principal Investigator: Geert Verheyden, KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: S64074; 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