Clinical trial NCT05316766: Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation
Official title: Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Interaction
Self Efficacy
Stroke
Motor Activity
Lead sponsor: Universidade da Madeira
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of conventional therapy with a framework intervention for upper limb motor rehabilitation based on the promotion of self-efficacy and social participation/interaction through a multi-user touch surface

Detailed description: After signing the written informed consent about participating in the study, participants will be assessed for exclusion criteria and their motor, social and depression skills prior to intervention. After this, they will undergo a 12 sessions treatment for 4 weeks in groups of three, randomly distributed for a control group and experimental group. At the end of the intervention, participants will be assessed in the same manner as before the intervention. One month after the end of the intervention, participants will be assessed for follow-up.

Eligibility criteria: Inclusion Criteria:

* Stroke survivor

Exclusion Criteria:

* Unable to write and read
* Hemispatial neglect
* Previous upper limb motor deficits/lesions that still interfere with function
* History of drugs/alcohol abuse
* Aphasia with difficulties understanding oral communication and/or unability to express orally
* Token equal or under 17
* ARAT score lower than 10 or higher than 54
* Botulinic toxin treatment in the last 4 months
* Beck's Depression Inventory higher than 31

Primary outcomes:
measure: Action Research Arm Test (change between three time frames )
timeFrame: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
measure: Box and Blocks (change between three time frames)
timeFrame: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
measure: Dynamometer (change between three time frames)
timeFrame: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
measure: Nine Hole Peg Test (change between three time frames)
timeFrame: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
measure: Motor Activity Log (change between three time frames)
timeFrame: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
measure: Reaching Performance Scale in Stroke (change between three time frames)
timeFrame: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
measure: Fugl-Meyer Assessment (change between three time frames)
timeFrame: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
measure: Stroke Self-Efficacy Questionnaire (change between three time frames)
timeFrame: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Secondary outcomes:
measure: Beck's Depression (change between three time frames)
timeFrame: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
measure: Social Interaction category of ''Functional Limitation Profile'' (specific name of the scale) (change between three time frames)
timeFrame: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Other outcomes:
Locations:
city: Funchal
country: Portugal
facility: ARDITI
state: Madeira
Study officials:
affiliation: Professor
name: Sergi B Badia
role: PRINCIPAL_INVESTIGATOR
References: