The Effect of Robot Assisted Hand Therapy on Hand Functions and Quality of Life in Patients With Spinal Cord Injury: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Jamar pinchmeter
研究概览
简要总结
Considering the scarcity of studies on robotic hand therapy, it has been seen that larger-scale and long-term follow-up studies are needed. In this study, our aim is to compare the effects of robot-assisted hand therapy and conventional physiotherapy on hand functions and quality of life in patients with spinal cord injury.
详细描述
Spinal cord injury (SCI) is considered one of the most devastating injuries that cause lifelong disability.Among the impaired functions, upper extremity function is one of the most important goals of rehabilitation for these individuals.Hand functions are among the most important determinants of independence.Some studies have reported that in more than half of people with tetraplegia, restoring arm and hand function will improve quality of life.Therefore, small improvements in upper extremity function can make a clinically significant difference in feeding, bathing, transferring and other functional activities.Given that the majority of individuals with spinal cord injuries are in their most productive years and life expectancy approaches that of the healthy population, more aggressive treatment strategies that focus on improving peripheral muscle control and recovery of the central nervous system (CNS) are needed.Recently, treatment based on the 'motor learning theory' has been reported to be effective in the recovery of impaired upper extremity function.It has been shown that by repetitive movements as intense as possible to help achieve the ultimate goal of optimum movement, patients are able to learn motor skills that lead to CNS recovery.It has also been suggested that repetitive and activity-based exercise may facilitate recovery after spinal cord injury by inducing practice-dependent brain and spinal cord plasticity.Therefore, repetitive, intensive, and activity-based upper extremity rehabilitative therapy can help improve impaired upper extremity function.In this context, robotic therapy (RT) may be an alternative way of delivering rehabilitative therapy to patients with tetraplegia, as RT can deliver consistently high-intensity, high-repetition, and task-specific training with less effort compared to conventional therapy.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mini mental test score >15
- •Able to understand the commands
- •Had a function between 1 and 4 in at least one of the key muscle strengths in at least one hand.
排除标准
- •Patients with persistent pain in the upper extremity (VAS>40)
- •Patients with severe spasticity in the hand (MAS≥3)
- •Patients with severe limitation of joint range of motion / contracture in the hand
- •Patients who had fractures or operations in the upper extremity in the last 6 months
- •Patients who received botulinum toxin injection to the upper extremity in the last 6 months
- •Patients with skin ulcers
- •Patients with severe visual impairment and severe depression
- •Patients who cannot sit in a chair for more than 30 minutes
- •Patients with a history of stroke or progressive neurodegenerative disease
- •Patients with neuromuscular disease
- •Patients with uncontrolled epilepsy
结局指标
主要结局
Jamar pinchmeter
时间窗: 5 minutes
The hand grip strength of the participants will be measured with the 'Jamar Hand Dynamometer'. Measurements will be made with the shoulder adjacent to the trunk in adduction and neutral rotation, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation with thumbs up. In the dominant and non-dominant hands, the measurements will be repeated three times (first right, then left and again right, etc.) with an interval of 5 seconds, and the average of the three measurements will be recorded in kilograms. The higher the score, the higher the success rate.
American spinal cord injury association impairment scale
时间窗: 15 minutes
The ASIA Evaluation determines the level of injury in patients with spinal cord injury (SCI) based on the levels of sensory, motor, and neurologic injury. Neurological injury level (NLI): NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided there is normal (integrated) sensory and motor function rostrally.
Sollerman hand function test
时间窗: 60 minutes
It consists of 20 different activities based on eight basic hand grips (pulp grip, lateral pinch, triple pinch, 5-finger pinch, diagonal volar grip, transverse volar grip, spherical volar grip, extension type grip). It also evaluates functional properties. Scoring of activities was done in the range of 0-4, according to the completion time of the activity. Failure to perform the activity 0, if it is performed in 60 seconds 1, if it is completed between 60-41 seconds or not with the desired grip pattern 2, if it is completed between 21-40 seconds and there is a minimum deviation in the grip pattern 3, if it is completed within 20 seconds with the specified grip pattern 4 points evaluated.The scoring rules were chosen so that subjects with normal hand function would achieve 80 points. As the score increases, the success rate of the test increases.
Nine Hole Peg Test
时间窗: 20 minutes
This test measures dexterity based on performance (in seconds). A wooden board with nine holes on it, 9 short wooden sticks and a box in which the wooden sticks can be placed are placed in front of the patient. Using the hand to be evaluated, the patient is asked to place the wooden sticks in the box into the holes on the panel as quickly as possible. Then, he is asked to put the sticks back into the box one by one. The completion time of the test is determined by a stopwatch. In this test, which evaluates manual dexterity based on performance, the success rate increases as the time gets shorter.
Box and block test
时间窗: 30 minutes
It is used to evaluate rough manual dexterity based on performance (time). 150 small wooden cubes are filled from the box with the patient's hand to be tested into the adjacent box. The patient is asked to throw one cube at a time into the semi-empty box. How many cubes are thrown in 60 seconds is counted. The result gives the score. How many cubes are thrown in 60 seconds is counted. The result gives the score. The higher the score, the higher the success rate.
Jamar hand dynamometer
时间窗: 5 minutes
Finger grip strength will be evaluated with a 'Jamar digital pinchmeter'. Patients will be placed in a sitting position with the wrist in 90° flexion and the forearm in a neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg.The higher the score, the higher the success rate
次要结局
- Short form 36(15 minutes)
- Modified Ashworth Scale(10 minutes)
- Spinal cord injury independence scale(15 minutes)
- Functional Independence Scale(15 minutes)
研究者
Sevda Adar
assistant professor
Afyonkarahisar Health Sciences University