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Development and Validation of Mobile Application for Upper Limb Function in Stroke Survivors

2026年7月24日 更新者：Lahore University of Biological and Applied Sciences
impairments that limit functional independence. This study aims to develop and validate a bilingual (English and Urdu) mobile application to improve upper limb function in stroke survivors through structured, task-oriented exercises. It will be conducted in two phases: app development and validation, followed by a pilot randomized controlled trial. A total of 20 participants will be recruited using convenience sampling and randomly assigned to either a clinical exercise-based group or an app-based training group, with allocation concealment ensured through sealed envelopes. The study will follow a double-blinded design, where both participants and the outcome assessor will be blinded. Outcomes will be measured using the Wolf Motor Function Test (WMFT), Fugl- Meyer Assessment (FMA), and Nine Hole Peg Test (NHPT). The study aims to provide an accessible, evidence-based digital solution to enhance functional recovery and improve quality of life in stroke survivors.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Stroke is a leading cause of long-term disability, often resulting in significant upper limb impairments that affect motor ability, coordination, and independence in daily activities. This study aims to develop and validate a bilingual (English and Urdu) mobile application designed to improve upper limb function in stroke survivors through structured, task-oriented rehabilitation exercises. The application will provide an accessible platform for home-based therapy, promoting patient engagement, continuous monitoring, and functional recovery. The study will be conducted in two phases: the first phase will focus on the development and validation of the mobile application, while the second phase will involve a pilot randomized controlled trial to evaluate its usability and effectiveness. A total of 20 stroke patients will be recruited using a convenience sampling technique. After initial screening, participants will be randomly allocated into two groups: a clinical exercise-based group and an app-based upper extremity training group using an online randomization tool. Allocation concealment will be ensured through the sealed envelope method to minimize selection bias. The study will follow a double-blinded design, where both participants and the outcome assessor will be blinded; the assessor will remain unaware of group allocation, and participants will be blinded to the study hypothesis. The effectiveness of the intervention will be evaluated using standardized outcome measures, including the Wolf Motor Function Test (WMFT) to assess motor ability, the Fugl-Meyer Assessment (FMA) to evaluate motor impairment, and the Nine Hole Peg Test (NHPT) to measure fine motor dexterity. By integrating evidence-based rehabilitation with a bilingual digital platform, this study aims to provide a comprehensive and accessible intervention that can enhance functional outcomes, promote independence in daily activities, and improve the overall quality of life for stroke survivors.

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 巴基斯坦
    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦
        • Lahore University of Biological and Applied Sciences
        • 接触：
      • Lahore、Punjab Province、巴基斯坦、54000
        • Services Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

Subacute and chronic stroke patient > 3 months post stroke. Modified Ashworth scale <3 MOCA > 24. An ability to understand the command First ever stroke Grade II, III, IV on Functional mobility Scale Able to use and comprehend smart phone.

Exclusion Criteria:

Posterior circulation stroke. Vestibular disorders, paroxysmal vertigo Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome Presence of orthopedic diseases involving the upper limb

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Clinical Exercise group
Participants in the Clinical Exercise-Based Group will receive standard physiotherapy in a clinical setting, including range-of-motion, strengthening, task-specific functional, and repetitive motor exercises for the affected upper limb. Sessions will be conducted 3 times per week for 45 minutes over 8 weeks following standardized clinical protocols.
其他：Routine Physical Therapy

Range-of-Motion Exercises:

Include passive, active-assisted, and active movements of the shoulder, elbow, wrist, and fingers along with stretching to maintain joint mobility and reduce stiffness.

Strengthening Exercises:

Involve resisted upper limb exercises using TheraBands, weights, and therapy tools to improve shoulder, elbow, forearm, wrist, and hand strength, including grip and pinch strengthening.

Task-Specific Functional Activities:

Focus on functional and daily-life tasks such as reaching, grasping, object manipulation, pegboard tasks, ADL simulations, fine motor activities, and repetitive bilateral upper-limb training to enhance coordination and motor recovery.
实验性的：m Health
Participants receive upper limb rehabilitation via a mobile app with structured exercises for range of motion, strengthening, and functional tasks targeting the shoulder, elbow, wrist, and hand to improve motor control and coordination. Sessions last 45 minutes, 3 times weekly for 8 weeks.
设备：mhealth

Progressive Training Plan (8 Weeks)

Phase I (Weeks 1-4): ROM & Early Activation:

  • Passive, active-assisted, and active range of motion exercises for shoulder, elbow, wrist, and hand
  • Light strengthening with TheraBand and scapular stabilization
  • Basic task practice (reaching, grasping, releasing objects) Dose:2-3 sets of 8-10 reps (tasks: 10-15 reps), rest 60-90 sec Focus: Improve mobility, reduce stiffness, and activate muscles

Phase II (Weeks 5-8): Strengthening & Functional Training:

  • Progressive resistance training for upper limb muscles
  • Hand grip and pinch strengthening
  • Advanced functional tasks (pegboard, object transfer, ADL simulation, bilateral activities) Dose:3-4 sets of 12-15 reps (tasks: 20-30 reps), rest 60-90 sec Focus: Increase strength, coordination, endurance, and functional recovery

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Wolf Motor Function Test
大体时间：The assesment will be done at baseline and after completion of 8 weeks.
The Wolf Motor Function Test (WMFT) is a standardized tool for assessing upper limb motor function in stroke survivors (Wolf et al., 2001). It includes 17 tasks: 15 timed functional activities (e.g., lifting objects, stacking) and 2 strength measures (grip and pinch). It evaluates movement speed, function, and quality, with performance rated on a 6-point scale (0-5) and faster times indicating better ability. The WMFT has high reliability (ICC > 0.90) and strong validity, correlating well with FMA and ARAT.
The assesment will be done at baseline and after completion of 8 weeks.
Fugl-Meyer Assessment - Upper Extremity
大体时间：The assesment will be done at baseline and after completion of 8 weeks.
The Fugl-Meyer Assessment (FMA) is a widely used tool to measure motor impairment after stroke (Fugl-Meyer et al., 1975). It evaluates upper limb function including reflexes, coordination, and voluntary movement of the shoulder, elbow, wrist, and hand. The total score ranges up to 66, with higher scores indicating better motor recovery. Each item is scored from 0 to 2, and the sum reflects overall performance. It has excellent reliability (ICC > 0.95) and strong validity for tracking motor recovery over time.
The assesment will be done at baseline and after completion of 8 weeks.
Nine Hole Peg Test
大体时间：The assesment will be done at baseline and after completion of 8 weeks.
The Nine-Hole Peg Test (NHPT) is a standardized, timed assessment used to measure fine motor dexterity of the upper limb (Mathiowetz et al., 1985). Participants place and remove nine pegs from a pegboard as quickly as possible, and performance is recorded in seconds. Lower completion time indicates better dexterity. It shows high reliability (ICC 0.88-0.99) and strong validity in stroke and other neurological conditions.
The assesment will be done at baseline and after completion of 8 weeks.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Lahore University of Biological and Applied Sciences

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月15日

初级完成 (估计的)

2027年2月10日

研究完成 (估计的)

2027年2月10日

研究注册日期

首次提交

2026年7月24日

首先提交符合 QC 标准的

2026年7月24日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月24日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UBAS/ERB/26/04/036 Haziqa

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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