Evaluation of upper limb motor performances using tablet-based tests

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00009022
• Date of registration: 07/08/2015
• Prospective Registration: No
• Primary sponsor: ReHaptix GmbH
• Public title: Evaluation of upper limb motor performances using tablet-based tests
• Scientific title: Evaluation of upper limb motor performances using tablet-based tests
• Date of first enrolment: 03/08/2015
• Target sample size: 160
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00009022
• Study type: interventional
• Study design: Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: other; Study design purpose: diagnostic
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Jan Kool
• Affiliation: Kliniken Valens

• Name: Marie-Christine Fluet
• Affiliation: ReHaptix GmbH

Key inclusion & exclusion criteria

Inclusion criteria: Healthy subjects will be eligible for the study if they have full hand function and can perform any activity of daily living involving the hands.
Impaired subjects will be eligible for the study if they are mildly to moderately impaired. They should be capable to perform minimal arm and hand movements but suffer from impaired motor function hindering typical activities of daily living.
Exclusion criteria: Healthy subjects will not be eligible for the study if they suffer from impaired motor function hindering typical activities of daily living.
Impaired subjects will not be eligible for the study if they fully recovered and are not suffering from impaired motor function hindering typical activities of daily living.

Age minimum: 21 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Stroke, not specified as haemorrhage or infarction

Multiple sclerosis

Patients with stroke (I64), multiple sclerosis (G35), Parkinson disease (G20) and ataxia (R27) who suffers from arm disabilities
I64
G35
G20
R27
U50

Parkinson disease

Other lack of coordination

Intervention(s)

Group 1: We will collect data with healthy subjects of different age (6 age groups: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80) and gender (2 categories).
Four tests on a tablet will be repeated 5 times with each hand:
1) Trace a spiral
2) Trace a star
3) Follow the dot
4) Hit the targets
Group 2: Patients (stroke, multiple sclerosis, Parkinson disease and ataxia):
Four tests on a tablet will be repeated 5 times with each hand:
1) Trace a spiral
2) Trace a star
3) Follow the dot
4) Hit the targets
Movement observation:
1) Tremor at rest
2) Action or Postural Tremor of hands
3) Finger Taps
4) Rapid Alternating Movements of Hands
5) Finger-to-nose test
6) Finger-finger test
7) Drawing of the Archimedes’ spiral on a pre-drawn pattern
8) Dysmetria test
9) Plate tapping test

Primary Outcome(s)

The study aims at:
1) measuring performances of healthy subjects as reference norms for comparison with patients data
2) validate the results by comparing them to existing validated clinical measures
3) evaluating the test-retest reliability of the results

Secondary Outcome(s)

The study also aims at developing additional outcome measures for the tablet based tests by analysing performances from healthy subjects and patients.

Source(s) of Monetary Support

Kliniken Valens

ReHaptix GmbH

Ethics review

Status: Approved
Approval date: 24/07/2015
Contact:

Ethikkommission Kantonsspital St.Gallen /Haus 037 [Ethikkommission des Kantons St. Gallen]

Results

• URL: http://drks.de/search/en/trial/DRKS00009022#studyResults