Comparison of the Effects of Combined and Individual Robotic Hand Rehabilitation and Conventional Rehabilitation on Daily Living Activity, Upper Extremity Functional Results and Hand Strength in Patients With Post-stroke Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- ABILHAND stroke hand ability questionnaire assessment
研究概览
简要总结
Objective: The investigators compared the effectiveness of individual and combined application of conventional rehabilitation and robotic hand rehabilitation in post-stroke hemiplegia. The study design is an An assessor-blinded, prospective randomized comparison study.
Methods: Patients were randomly assigned to one of three groups:
Group 1 (Robotic Hand Rehabilitation): The patients underwent robotic hand rehabilitation, Group 2 (Conventional Rehabilitation): The patients underwent conventional rehabilitation, Group 3 (Combined Rehabilitation): The patients underwent combined conventional and robotic hand rehabilitation at the same period.
Randomization was performed using the closed envelope method randomization sequence by an investigator who was not involved in patient care. The therapist opened the envelope 6 hours before the patient started treatment.
The investigators assessed Barthel index for activities of daily living (range, 0 - 100), Brunnstrom's hemiplegia recovery staging (range, stage 1 - stage 7), Fugl-Meyer upper extremity assessment scale (stage, 0 - 66), Abilhand stroke hand ability questionnaire assessment (range, 0 - 46), hand grip strength, and hand pinch strength at baseline and end of the rehabilitation (1-month).
Conclusions: There are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke. They revealed that both therapies had a positive effect on the results. There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions. More successful hand functional results may be achieved by applying both rehabilitations together in stroke. The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke. Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity.
详细描述
Objective
Hemiplegia or hemiparesis is commonly seen after stroke.Upper limb function, particularly hand function, plays a crucial role in determining the quality of life and independence after stroke. Numerous studies have been conducted on rehabilitation to improve upper extremity function.There are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke. They revealed that both therapies had a positive effect on the results. There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions. More successful hand functional results may be achieved by applying both rehabilitations together in stroke. The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke. Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity.
Methods: 66 patients with post-stroke hemiplegia will include in our study. Grip strength was measured with a dynamometer (JamarR, PrestonTM, Jackson, MI) and pinch strength was measured with a specially designed instrument (Pinch gauge, B&R EngineeringTM, Santa Fe Springs, CA). Measurements were made 3 times and the average value was taken. The patients were evaluated before rehabilitation and at the first month follow-up. The same therapist who was blind to the type of rehabilitation evaluated the patients before treatment and at the first month follow-up.
Conclusions: Combined Rehabilitation achieves results just as successful as Conventional Rehabilitation in terms of daily living activities, upper extremity functions, and hand functions. Additionally, it significantly outperformed Conventional Rehabilitation in improving hand functions, treating hand spasticity, and enhancing hand strength.
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
- Single (Outcomes Assessor)
盲法说明
The patients were evaluated before rehabilitation and at the first month follow-up. The same therapist who was blind to the type of rehabilitation evaluated the patients before treatment and at the first month follow-up.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
ABILHAND stroke hand ability questionnaire assessment
时间窗: The patients were evaluated before rehabilitation and at the first month follow-up.
It was used to evaluate stroke hand function. Total score is between 0 - 46.
Barthel index for activities of daily living
时间窗: The patients were evaluated before rehabilitation and at the first month follow-up.
Barthel index was used to evaluate the daily living activities of the patients. Total score is between 0 - 100. 0 - 20 completely dependent, 21 - 61 highly dependent, 62 - 90 moderately dependent, 91 - 99 slightly dependent, 100 completely independent.
Fugl-Meyer upper extremity assessment scale
时间窗: The patients were evaluated before rehabilitation and at the first month follow-up.
It was used to evaluate upper extremity function. Total score is between 0 - 66.
grip strength, and pinch strength
时间窗: The patients were evaluated before rehabilitation and at the first month follow-up.
It was used to evaluate hand strength.
Brunnstrom's hemiplegia recovery staging
时间窗: The patients were evaluated before rehabilitation and at the first month follow-up.
It was used to evaluate hemiplegia recovery upper extremity. It has 7 stages. Stage 1: There is no movement in the held arm. It is flask. Stage 7: Normal motor function is regained.
次要结局
未报告次要终点
研究者
Betül Başar
Assistant Professor
Gaziosmanpasa Research and Education Hospital