Feasibility Study of a Virtual Reality Cognitive-motor Task Based on Positive Stimuli for Stroke Rehabilitation

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02539914
• Date of registration: 27/08/2015
• Prospective Registration: No
• Primary sponsor: Universidade da Madeira
• Public title: Feasibility Study of a Virtual Reality Cognitive-motor Task Based on Positive Stimuli for Stroke Rehabilitation
• Scientific title: Interactive System for Diagnostics and Rehabilitation of Cognitive-motor Deficits: Controlled Longitudinal Clinical Study With Stroke Patients
• Date of first enrolment: June 2015
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02539914
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Portugal

Contacts

• Name: Sergi Bermudez i Badia, PhD
• Affiliation: Universidade da Madeira

Key inclusion & exclusion criteria

Inclusion Criteria:

- ischemic or hemorrhagic stroke within the first 6 months post-stroke

- motor impairment of the upper extremity but with a minimum score of 28 in the
Motricity Index (elbow flexion and shoulder abduction domains combined score)

- cognitive deficit but with enough capacity to understand the task and follow
instructions with a minimum score of 11 over 17 in the Token Test (6-item version,
portuguese population)

- able to read

Exclusion Criteria:

- previous motor and/or cognitive deficits

- normal cognitive functioning with a score above 26 points in the Montreal Cognitive
Assessment

- unilateral spatial neglect

- moderate to severe depressive symptomatology with a score above 20 points in the
Geriatric Depression Scale

- vision disorders that may interfere with the execution of the task



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Other: Standard

Other: Virtual Reality

Primary Outcome(s)

Change form baseline in the Chedoke Arm and Hand Activity Inventory [Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up]

Change from baseline in the Montreal Cognitive Assessment [Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up]

Change from baseline in the Fugl-Meyer Assessment Test (upper extremity) [Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up]

Secondary Outcome(s)

Change from baseline in cancellation tests (single letter, number, bells) [Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up]

Change from baseline in the Modified Ashworth Scale [Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up]

Change from baseline in the Barthel Index [Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up]

Change from baseline in the Motricity Index (upper extremity) [Time Frame: Baseline, End (4-6 weeks) and 4-weeks follow-up]

Secondary ID(s)

303891- 47/2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.