Combined Robotic Hand Rehabilitation and Conventional Rehabilitation for Post-stroke Rehabilitation
- Conditions
- HemiplegiaStroke
- Interventions
- Other: Robotic hand rehabilitation
- Registration Number
- NCT06184191
- Lead Sponsor
- Gaziosmanpasa Research and Education Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robotic Hand Rehabilitation Robotic hand rehabilitation RHR group received hand rehabilitation through the robotic device. A home-based rehabilitation program was used to these patients for hand and upper extremity rehabilitation in addition to RHR. Each rehabilitation session consisted of six parts: 1. A sequence of 17 cycles of digital flexion-extension joint motions, from the thumb to the fifth finger (7 min). 2. A sequence of 23 cycles of motion to counting from one to five (7 min). 3. A sequence of 70 cycles of motions including thumb-finger opposition motions from the second to the fifth finger (7 min). 4. A sequence of 28 cycles of motions including wave-like finger motions (7 min). 5. A sequence of 42 cycles of motions including fist opening/closing (7 min). 6. A sequence of 20 cycles of motions including flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min). The patients underwent Robotic Hand Rehabilitation in the hospital 5 days per week for 1 month. Conventional Rehabilitation Robotic hand rehabilitation CVR group received 60 minutes of consecutive occupational therapy sessions in the hospital 5 days per week for 1 month. The rehabilitation program involved strength, balance, manual dexterity exercises, and stretching/weight-bearing by the affected arm. Treatments focused on practice of specific functional tasks when possible. These included reach and grasp of various objects, isolated hand motions (writing, playing an instruments, molding putty, cooking), and whole body activities (swinging a racquet, basketball handling skills). The rehabilitation also included training in ADLs. The patients underwent individualized programs based on assessment and patient goals. Manual therapy techniques were used to obtain isometric contractions in weak muscles. The patients received mobilization and stretching exercises to restricted joints as needed to increase range of motion. Combined Rehabilitation Robotic hand rehabilitation The patients underwent 60 minutes of CVR followed by 40 minutes of hand rehabilitation through the robotic device. A home-based rehabilitation was not involve in this group.
- Primary Outcome Measures
Name Time Method ABILHAND stroke hand ability questionnaire assessment 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gaziosmanpaşa Training and Research Hospital
🇹🇷Istanbul, Gaziosmanpaşa, Turkey