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

NCT04430153 | Completed

• 2 other identifiers: S640741153320N
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• National Institutes of Health Stroke Scale (NIHSS)

  After inclusion

• Modified Rankin Scale (mRS)

  After inclusion

• Montreal Cognitive Assessment (MoCA)

  After inclusion

• Start Cancellation Test (SCT)

  After inclusion

• Hospital Anxiety and Depression Scale (HADS)

  After inclusion

Study Arms (3)

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

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

Mismatch

A group with good observed but low perceived function.

Other: "Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer

Interventions

"Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer OTHER

Accelerometers on both patients' wrists will give insight into the daily life upper limb use.

Good match; Low match; Mismatch

Eligibility Criteria

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

Study Population

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

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Research Foundation Flanders: collaborator

Study Sites (1)

UZ Leuven

Leuven, 3001, 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

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: October 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)