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临床试验/CTRI/2024/04/065643
CTRI/2024/04/065643尚未招募4 期

Influence of Mobility related Environmental Enrichment on Motivation in Stroke Survivors

未提供1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年4月19日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
68
试验地点
1
主要终点
1. Determinants of Physical Activity Questionnaire

研究概览

简要总结

BACKGROUND : One of the  most disabling outcomes of stroke has been found as a limitation in community walking. More than 80% of stroke patients experience walking difficulties, which ultimately restricts their capacity to carry out everyday tasks and interact  with others in the community. Thus, identifying the   environmental features and ultimately changing the environment to be more accessible has the potential to increase walking in the community.

OBJECTIVE: To identify the influence of environmental enrichment on motivation in stroke survivors.

DESIGN : Randomised, parallel group, multiple arm trail.

SETTING :Physiotherapy department in Stroke rehabilitation centers, Physiotherapy OPD’s and Neuro physiotherapy clinics in Bangalore.

PARTICIPANTS:  68 participants will be randomly allocated through concealed allocation into 4 groups which is based on the levels of enriched environment.

INTERVENTION: A semi-standardized interview will be conducted for 68 participants. Interviews with participants will be tape recorded, audio files will be transcribed verbatim. Pre- assessment will be done using scales. The facilitators and barriers for each participant will be noted from the interview. Based upon the groups, they are in, intervention will be provided for 4 weeks using “Action Statement”. 4 week- intervention programme will be given for 40 minutes, 5 days per week.  Post- assessment will be done after 4 weeks of intervention using outcome measures.

MAIN OUTCOME MEASURES : The Primary Outcome Measures will measure the levels of motivation using self report questionnaires at baseline and post intervention. The following outcome measures will be used : Determinants of Physical Activity Questionnaire (DPAQ), Self Efficacy for Exercise (SEE), Stages of Change Questionnaire and Intentional scales.  These questionnaires will be translated into community mobility.

DATA  ANALYSIS : The data collected  between group analysis will be done using Mann-Whitney U Test to find out whether enrichment changes motivation levels in patients

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Participants who are diagnosed with ischemic/ hemorrhagic stroke confirmed on CT or MRI.
  • Male and Female participants.
  • Stroke survivors above 18 years of age.
  • Sub-acute and Chronic stage stroke survivor.
  • Participants who are mobile with or without assistive devices.

排除标准

  • Participants diagnosed without Neurological or Neuromuscular Disorder.
  • Participants who are with cognitive deficits i.e., MMSE score less than 18
  • Participants who are not willing to participate in the study.
  • • Participants with acute lower limb injury.

结局指标

主要结局

1. Determinants of Physical Activity Questionnaire

时间窗: Baseline -0 | Post Intervention - 4 weeks

2. Self efficacy for Exercise

时间窗: Baseline -0 | Post Intervention - 4 weeks

3. Stages of Change questionnaire

时间窗: Baseline -0 | Post Intervention - 4 weeks

4. Intention scales

时间窗: Baseline -0 | Post Intervention - 4 weeks

5. Perceived Barriers to Community mobility Questionnaire

时间窗: Baseline -0 | Post Intervention - 4 weeks

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Subhicha R S

The Oxford College of Physiotherapy

研究点 (1)

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