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

NCT05316766 | Completed

• 1 other identifier: UMadeira
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Social Interaction; Self Efficacy; Stroke; Motor Activity

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• 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)

• 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)

Study Arms (2)

Intervention

EXPERIMENTAL

Will receive intervention through the multi-user touch surface

Other: Physical rehabilitation interactive table

Treatment as usual

ACTIVE COMPARATOR

This will receive conventional therapy

Other: Physical rehabilitation

Interventions

Physical rehabilitation OTHER

Exercises to rehabilitate upper limb strength, coordination and range of movement, based on conventional therapy

Treatment as usual

Physical rehabilitation interactive table OTHER

Exercises to rehabilitate upper limb strength, coordination and range of movement, based on multi-user touch surface

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivor

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade da Madeira: lead

Study Sites (1)

ARDITI

Funchal, Madeira, 9000-232, Portugal

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Sergi B Badia

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 7, 2022
• Study Start: March 29, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)