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

Primary Purpose

Social Interaction, Self Efficacy, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Physical rehabilitation
Physical rehabilitation interactive table
Sponsored by
Universidade da Madeira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Interaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ARDITIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Treatment as usual

Arm Description

Will receive intervention through the multi-user touch surface

This will receive conventional therapy

Outcomes

Primary Outcome Measures

Action Research Arm Test (change between three time frames )
Hand Function
Box and Blocks (change between three time frames)
Coordination
Dynamometer (change between three time frames)
Strength
Nine Hole Peg Test (change between three time frames)
Fine motor skills
Motor Activity Log (change between three time frames)
Quantity and Quality of movement everyday activities
Reaching Performance Scale in Stroke (change between three time frames)
Quality of movement
Fugl-Meyer Assessment (change between three time frames)
Range of movement
Stroke Self-Efficacy Questionnaire (change between three time frames)
Self-efficacy, minimum 0 maximum 130, higher score means better outcome

Secondary Outcome Measures

Beck's Depression (change between three time frames)
Depressive symptoms
Social Interaction category of ''Functional Limitation Profile'' (specific name of the scale) (change between three time frames)
Social Interaction

Full Information

First Posted
March 2, 2022
Last Updated
May 10, 2023
Sponsor
Universidade da Madeira
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1. Study Identification

Unique Protocol Identification Number
NCT05316766
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
November 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Madeira

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Interaction, Self Efficacy, Stroke, Motor Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Will receive intervention through the multi-user touch surface
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
This will receive conventional therapy
Intervention Type
Other
Intervention Name(s)
Physical rehabilitation
Intervention Description
Exercises to rehabilitate upper limb strength, coordination and range of movement, based on conventional therapy
Intervention Type
Other
Intervention Name(s)
Physical rehabilitation interactive table
Intervention Description
Exercises to rehabilitate upper limb strength, coordination and range of movement, based on multi-user touch surface
Primary Outcome Measure Information:
Title
Action Research Arm Test (change between three time frames )
Description
Hand Function
Time Frame
Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Title
Box and Blocks (change between three time frames)
Description
Coordination
Time Frame
Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Title
Dynamometer (change between three time frames)
Description
Strength
Time Frame
Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Title
Nine Hole Peg Test (change between three time frames)
Description
Fine motor skills
Time Frame
Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Title
Motor Activity Log (change between three time frames)
Description
Quantity and Quality of movement everyday activities
Time Frame
Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Title
Reaching Performance Scale in Stroke (change between three time frames)
Description
Quality of movement
Time Frame
Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Title
Fugl-Meyer Assessment (change between three time frames)
Description
Range of movement
Time Frame
Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Title
Stroke Self-Efficacy Questionnaire (change between three time frames)
Description
Self-efficacy, minimum 0 maximum 130, higher score means better outcome
Time Frame
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 Measure Information:
Title
Beck's Depression (change between three time frames)
Description
Depressive symptoms
Time Frame
Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Title
Social Interaction category of ''Functional Limitation Profile'' (specific name of the scale) (change between three time frames)
Description
Social Interaction
Time Frame
Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fábio DS Pereira
Phone
917499898
Email
fabiodsp7@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergi B Badia
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
ARDITI
City
Funchal
State/Province
Madeira
ZIP/Postal Code
9000-232
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fábio DS Pereira
Phone
917499898
Email
fabiodsp7@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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