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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Motor Activity; Self Efficacy; Social Interaction
• Intervention / Treatment: Other: Physical rehabilitation interactive table; Other: Physical rehabilitation

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Madeira
    • Funchal, Madeira, Portugal, 9000-232
      • ARDITI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Will receive intervention through the multi-user touch surface	Other: Physical rehabilitation interactive table; Exercises to rehabilitate upper limb strength, coordination and range of movement, based on multi-user touch surface
Active Comparator: Treatment as usual; This will receive conventional therapy	Other: Physical rehabilitation; Exercises to rehabilitate upper limb strength, coordination and range of movement, based on conventional therapy

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators and Investigators

• Sponsor: Universidade da Madeira
• Investigators: Principal Investigator: Sergi B Badia, PROFESSOR

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: UMadeira

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No