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Completed

NCT Number: NCT04430153

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3001, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. Bilateral magnitude

    Time frame: After 3 days of sensor-based assessment

    Sum of the vector magnitude from the two limbs

Secondary outcomes

  1. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: After inclusion

    Stroke severity. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.

  2. Modified Rankin Scale (mRS)

    Time frame: After inclusion

    Disability. Minimum: 0. Maximum: 42. Higher scores mean worse outcome. Minimum: 0. Maximum: 6. Higher scores mean worse outcome.

  3. Montreal Cognitive Assessment (MoCA)

    Time frame: After inclusion

    Cognitive impairment. Minimum: 0. Maximum: 30. Higher scores mean better outcome.

  4. Start Cancellation Test (SCT)

    Time frame: After inclusion

    Unilateral spatial neglect. Min: 0. Max: 54. Higher scores are better, scores <44 indicate the presence of USN.

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: After inclusion

    Anxiety and depression. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.

  6. Barthel Index (BI)

    Time frame: After inclusion

    Independence in activities of daily living. Minimum: 0. Maximum: 100. Higher scores mean better outcome.

  7. Functional Ambulation Categories (FAC)

    Time frame: After inclusion

    Walking ability. Minimum: 0. Maximum: 5. Higher scores mean better outcome.

  8. International Physical Activity Questionnaire (IPAQ)

    Time frame: After inclusion

    Patient-reported physical activity. 3 levels, higher levels are better.

  9. Motor Activity Log Amount of Use (MAL AOU) - Dutch version

    Time frame: After inclusion

    Amount the individual uses the paretic arm. 26 items, per item: min. 0, max. 5. Higher scores mean better outcome.

  10. ABILHAND

    Time frame: After inclusion

    Self-reported measure of (bi)manual ability in everyday activities. Rasch based logit scale. Higher logit scores mean better outcome.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Research Foundation Flanders
  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2020
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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