Remote handling concept based task-oriented arm training (ReHab-TOAT) in chronic stroke: an RCT

Remote handling concept based task-oriented arm training (ReHab-TOAT) in chronic stroke: an RCT - ReHab-TOAT in chronic stroke: an RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52340

Enrollment

Registered

2021-07-12

Start date

2021-09-13

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemiparesis Stroke

Interventions

Participants in the EXP group receive ReHab-TOAT (Remote Handling Based Task-Oriented Arm Training). ReHab-TOAT contains task-oriented arm training for stroke patients in combination with haptic fee

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Regarding patients: - An unilateral stroke (ischemic or haemorrhagic) confirmed by brain imaging; - Post-stroke time larger than 12 months; - Hemiplegic pattern of arm motor impairment with UAT score 1-3; - Age 18 years or older; - Sufficient cognitive level, i.e. being able to understand the questionnaires and measurement instructions. Regarding patients' caregivers: - Age 18 years or older; - providing informal care to stroke patients from the group mentioned above.

Exclusion criteria

Exclusion criteria: Regarding patients: - Severe non-stroke related co-morbidity that may interfere with arm-hand function; - Additional complaints that may interfere with the execution of the measurements; - Spasticity in the affected upper limb, i.e. a Modified Ashworth Scale (MAS) score >= 1+; - Severe cognitive problems that prevent the patient from understanding the tasks; - No informed consent. Regarding patients' caregivers: - No informed consent.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure for this RCT is the Brunnstrom-Fugl Meyer Test (BFMT).	—

Secondary

Measure	Time frame
The secundary outcome measures for the patiens/participants are: - Action research ARM Test (ARAT); - Motor Activity Log (MAL); - Accelerometry / gyroscopy; - EuroQoL-5D. In addition, the following questionnaires are administered to the persons from the EXP group for the purpose of evaluating the technology used: - System Usability Scale (SUS) - Questionnaire on experience with the technology used. All patient participants will also be asked a single question gauging the occurrence of any event over the last 2 weeks that may influence the results of the treatment or the measurements (e.g. the patient having had the flu in the past 2 weeks). Regarding the caregivers, the CarerQoL questionnaire will be administered. Also a single question gauging the caregiver's amount of care provided to the patient will be posed.	—

Measure

Time frame

The secundary outcome measures for the patiens/participants are: - Action research ARM Test (ARAT); - Motor Activity Log (MAL); - Accelerometry / gyroscopy; - EuroQoL-5D. In addition, the following questionnaires are administered to the persons from the EXP group for the purpose of evaluating the technology used: - System Usability Scale (SUS) - Questionnaire on experience with the technology used. All patient participants will also be asked a single question gauging the occurrence of any event over the last 2 weeks that may influence the results of the treatment or the measurements (e.g. the patient having had the flu in the past 2 weeks). Regarding the caregivers, the CarerQoL questionnaire will be administered. Also a single question gauging the caregiver's amount of care provided to the patient will be posed.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)