Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation

Not Applicable

Completed

• Conditions: Social Interaction; Self Efficacy; Motor Activity; Stroke
• Interventions: Other: Physical rehabilitation; Other: Physical rehabilitation interactive table

• Registration Number: NCT05316766
• Lead Sponsor: Universidade da Madeira

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.

Study Timeline

• Study First Submitted: 2022-03-02
• Study Start: 2022-03-29
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Physical rehabilitation	This will receive conventional therapy
Intervention	Physical rehabilitation interactive table	Will receive intervention through the multi-user touch surface

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (change between three time frames )	Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)	Hand Function
Dynamometer (change between three time frames)	Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)	Strength
Motor Activity Log (change between three time frames)	Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)	Quantity and Quality of movement everyday activities
Reaching Performance Scale in Stroke (change between three time frames)	Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)	Quality of movement
Stroke Self-Efficacy Questionnaire (change between three time frames)	Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)	Self-efficacy, minimum 0 maximum 130, higher score means better outcome
Box and Blocks (change between three time frames)	Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)	Coordination
Nine Hole Peg Test (change between three time frames)	Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)	Fine motor skills
Fugl-Meyer Assessment (change between three time frames)	Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)	Range of movement

Secondary Outcome Measures

Name	Time	Method
Beck's Depression (change between three time frames)	Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)	Depressive symptoms
Social Interaction category of ''Functional Limitation Profile'' (specific name of the scale) (change between three time frames)	Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)	Social Interaction

Trial Locations

Locations (1)

ARDITI; 🇵🇹 Funchal, Madeira, Portugal