跳至主要内容
临床试验/CTRI/2025/07/090708
CTRI/2025/07/090708尚未招募2 期

Development and testing of a remote-controlled balance board for independent use of stroke subjects: An exploratory study

Urvi Kanjariya1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
berg balance scale

研究概览

简要总结

Need for Study:

There is a growing demand for rehabilitation tools that allow patients with limited mobility to engage in balance training more safely and independently. By integrating a remote-control mechanism, the proposed device aims to empower users to perform balance activities with less dependence on a therapist. This could enhance patient safety, confidence, and engagement. Moreover, the study intends to assess how the innovative design impacts rehabilitation outcomes, especially for users with high body weight or varying balance abilities.

Aim:

To develop and test a remote-controlled balance board for independent use by stroke patients.

Objectives:

  1. To develop a functional prototype of a balance board that can be operated via remote control.

  2. To assess ease of use, patient experience, and safety in normal individuals using the remote-controlled balance board.

  3. To determine whether the device enhances balance training outcomes and reduces dependence on therapist support in stroke patients.

Methodology:

The study will be conducted over 4 weeks and divided into three phases:

Phase I—Development Phase:

Design and development of the remote-controlled balance board prototype, focusing on portability, safety, weight capacity, and adjustable tilting features.

Phase II—Preliminary Testing Phase:

Testing the device on healthy adult individuals to evaluate its safety, functionality, and ease of use. Feedback from this phase will be used to make necessary modifications.

Phase III—Stroke Subject Phase:

Implementation of the device with stroke patients, comparing the outcomes of those using the balance board in addition to conventional physiotherapy versus those receiving only conventional treatment.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
22.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • MMSE score more than equal to 24 medically stable post stroke patients.

排除标准

  • Subjects not willing to participate Severe vestibular disorders pregnancy severe musculoskeletal conditions severe cognitive impairments visual impairments.

结局指标

主要结局

berg balance scale

时间窗: before and after 4 weeks of intervention

system usability scale

时间窗: before and after 4 weeks of intervention

次要结局

  • no(no)

研究者

发起方
Urvi Kanjariya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Urvi Kanjariya

Marwadi University

研究点 (1)

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