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

Sponsor
Universidade da Madeira (Other)
Overall Status
Recruiting
CT.gov ID
NCT05316766
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
23.3
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Physical rehabilitation
  • Other: Physical rehabilitation interactive table
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation
Actual Study Start Date :
Mar 29, 2022
Anticipated Primary Completion Date :
Mar 7, 2024
Anticipated Study Completion Date :
Mar 7, 2024

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Secondary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1ARDITIFunchalMadeiraPortugal9000-232

Sponsors and Collaborators

  • Universidade da Madeira

Investigators

  • Principal Investigator: Sergi B Badia, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sergi Bermúdez i Badia, Professor, Universidade da Madeira
ClinicalTrials.gov Identifier:
NCT05316766
Other Study ID Numbers:
  • UMadeira
First Posted:
Apr 7, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022