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Completed

NCT Number: NCT05316766

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

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Key information

Conditions

Social Interaction Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Self Efficacy Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ARDITI

Funchal, Madeira, 9000-232, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical rehabilitation

Other

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

Physical rehabilitation interactive table

Other

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

Primary outcomes

  1. Action Research Arm Test (change between three time frames )

    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)

    Hand Function

  2. Box and Blocks (change between three time frames)

    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)

    Coordination

  3. Dynamometer (change between three time frames)

    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)

    Strength

  4. Nine Hole Peg Test (change between three time frames)

    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)

    Fine motor skills

  5. Motor Activity Log (change between three time frames)

    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)

    Quantity and Quality of movement everyday activities

  6. Reaching Performance Scale in Stroke (change between three time frames)

    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)

    Quality of movement

  7. Fugl-Meyer Assessment (change between three time frames)

    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)

    Range of movement

  8. Stroke Self-Efficacy Questionnaire (change between three time frames)

    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)

    Self-efficacy, minimum 0 maximum 130, higher score means better outcome

Secondary outcomes

  1. Beck's Depression (change between three time frames)

    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)

    Depressive symptoms

  2. Social Interaction category of ''Functional Limitation Profile'' (specific name of the scale) (change between three time frames)

    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)

    Social Interaction

Sponsors and collaborators

Lead sponsor

Universidade da Madeira

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2022
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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