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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05316766
• Other study ID #: UMadeira
• Status: Completed
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2023
• Source: Universidade da Madeira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Motor Activity
• Self Efficacy
• Social Interaction
• Stroke

Intervention

Other:
• Physical rehabilitation
Exercises to rehabilitate upper limb strength, coordination and range of movement, based on conventional therapy
• Physical rehabilitation interactive table
Exercises to rehabilitate upper limb strength, coordination and range of movement, based on multi-user touch surface

Locations

Country	Name	City	State
Portugal	ARDITI	Funchal	Madeira

Sponsors (1)

Lead Sponsor	Collaborator
Universidade da Madeira

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Beck's Depression (change between three time frames)	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)
Secondary	Social Interaction category of ''Functional Limitation Profile'' (specific name of the scale) (change between three time frames)	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)