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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430153
• Other study ID #: S64074
• Secondary ID: 1153320N
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: June 2021
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
KU Leuven	Research Foundation Flanders, Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Hours of use of each limb	Hours of use of each limb as measured with the accelerometer	After 3 days of sensor-based assessment
Primary	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
Primary	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
Primary	Bilateral magnitude	Sum of the vector magnitude from the two limbs	After 3 days of sensor-based assessment
Secondary	National Institutes of Health Stroke Scale (NIHSS)	Stroke severity. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.	After inclusion
Secondary	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
Secondary	Montreal Cognitive Assessment (MoCA)	Cognitive impairment. Minimum: 0. Maximum: 30. Higher scores mean better outcome.	After inclusion
Secondary	Start Cancellation Test (SCT)	Unilateral spatial neglect. Min: 0. Max: 54. Higher scores are better, scores <44 indicate the presence of USN.	After inclusion
Secondary	Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.	After inclusion
Secondary	Barthel Index (BI)	Independence in activities of daily living. Minimum: 0. Maximum: 100. Higher scores mean better outcome.	After inclusion
Secondary	Functional Ambulation Categories (FAC)	Walking ability. Minimum: 0. Maximum: 5. Higher scores mean better outcome.	After inclusion
Secondary	International Physical Activity Questionnaire (IPAQ)	Patient-reported physical activity. 3 levels, higher levels are better.	After inclusion
Secondary	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
Secondary	ABILHAND	Self-reported measure of (bi)manual ability in everyday activities. Rasch based logit scale. Higher logit scores mean better outcome.	After inclusion