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临床试验/NCT05316766
NCT05316766已完成不适用

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

Universidade da Madeira2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Action Research Arm Test (change between three time frames )

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke survivor

排除标准

  • 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

结局指标

主要结局

Action Research Arm Test (change between three time frames )

时间窗: 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

Dynamometer (change between three time frames)

时间窗: 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

Motor Activity Log (change between three time frames)

时间窗: 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)

时间窗: 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

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

时间窗: 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

Box and Blocks (change between three time frames)

时间窗: 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

Nine Hole Peg Test (change between three time frames)

时间窗: 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

Fugl-Meyer Assessment (change between three time frames)

时间窗: 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

次要结局

  • 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))
  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergi Bermúdez i Badia

Professor

Universidade da Madeira

研究点 (2)

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