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

November 29, 2023 updated by: Sergi Bermúdez i Badia, Universidade da Madeira
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade da Madeira

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sergi B Badia, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings