Social InteractionNCT05316766
Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation
A study testing Physical rehabilitation and Physical rehabilitation interactive table in people with Social Interaction and Self Efficacy, run by Universidade da Madeira at 1 site in Portugal.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Interaction, Self Efficacy, Stroke
- What is being tested?
- Physical rehabilitation and Physical rehabilitation interactive table
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePortugal
- Study dates
- 29 Mar 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke survivor
Who cannot join
- 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
Show all 9Show fewer
- ARAT score lower than 10 or higher than 54
- Botulinic toxin treatment in the last 4 months
- Beck's Depression Inventory higher than 31
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Social Interaction, Self Efficacy, Stroke, Motor Activity
- Being tested
- Physical rehabilitation, Physical rehabilitation interactive table
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical rehabilitationOther
Exercises to rehabilitate upper limb strength, coordination and range of movement, based on conventional therapy
Physical rehabilitation interactive tableOther
Exercises to rehabilitate upper limb strength, coordination and range of movement, based on multi-user touch surface
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Will receive intervention through the multi-user touch surface Receives: Other: Physical rehabilitation interactive table |
| Treatment as usual | Active comparator | This will receive conventional therapy Receives: Other: Physical rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (change between three time frames )
Hand Function
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Depressive symptoms
Measured: 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)
Social Interaction
Measured: Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start29 Mar 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Madeira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergi Bermúdez i Badia, Universidade da Madeira
- Investigators
- Sergi B Badia, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316766
- Sponsor's protocol ID
- UMadeira
- Status last verified
- Nov 2023
- First submitted
- 2 Mar 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT05316766
- Acronym / sponsor ID
- UMadeira
- Conditions
- Social Interaction, Self Efficacy, Stroke, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidade da MadeiraUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Physical rehabilitation interactive tableWill receive intervention through the multi-user touch surface |
| Treatment as usual | Active comparator | Other: Physical rehabilitationThis will receive conventional therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stroke survivor
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical rehabilitationExercises to rehabilitate upper limb strength, coordination and range of movement, based on conventional therapy | Other | Treatment as usual |
| Physical rehabilitation interactive tableExercises to rehabilitate upper limb strength, coordination and range of movement, based on multi-user touch surface | Other | Intervention |
Primary outcome
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
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
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
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
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
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
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
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
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergi B Badia principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical rehabilitation and Physical rehabilitation interactive table in people with Social Interaction and Self Efficacy, run by Universidade da Madeira at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.