Skip to main content
Clinical Trials/NCT04430153
NCT04430153
Completed
Not Applicable

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

KU Leuven1 site in 1 country60 target enrollmentOctober 1, 2020
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
KU Leuven
Enrollment
60
Locations
1
Primary Endpoint
Hours of use of each limb
Status
Completed
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
May 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Prof Geert Verheyden

Professor

KU Leuven

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Hours of use of each limb

Time Frame: After 3 days of sensor-based assessment

Hours of use of each limb as measured with the accelerometer

Bilateral magnitude

Time Frame: After 3 days of sensor-based assessment

Sum of the vector magnitude from the two limbs

Fugl-Meyer motor assessment - upper extremity

Time Frame: After inclusion

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.

Stroke Impact Scale 3.0

Time Frame: After inclusion

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.

Use ratio

Time Frame: After 3 days of sensor-based assessment

Dividing hours of use of the affected limb by the hours of use of the non-affected limb

Magnitude ratio

Time Frame: After 3 days of sensor-based assessment

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

Secondary Outcomes

  • Montreal Cognitive Assessment (MoCA)(After inclusion)
  • Hospital Anxiety and Depression Scale (HADS)(After inclusion)
  • Barthel Index (BI)(After inclusion)
  • Modified Rankin Scale (mRS)(After inclusion)
  • Functional Ambulation Categories (FAC)(After inclusion)
  • Start Cancellation Test (SCT)(After inclusion)
  • Motor Activity Log Amount of Use (MAL AOU) - Dutch version(After inclusion)
  • National Institutes of Health Stroke Scale (NIHSS)(After inclusion)
  • ABILHAND(After inclusion)
  • International Physical Activity Questionnaire (IPAQ)(After inclusion)

Study Sites (1)

Loading locations...

Similar Trials