The Effect of Combined Robotic Hand Therapy and Conventional Therapy in Stroke Patients

Afyonkarahisar Health Sciences University

Status: Completed

Conditions: Stroke; Robot Assisted Therapy; Robotic Rehabilitation

Treatments: Procedure: Conventional Therapy Group; Procedure: Robot assisted therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05601115

SASHR22

Details and patient eligibility

About

RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.The aim of tihis study is to investigate the effect of robotic hand therapy added to conventional rehabilitation on rehabilitation outcomes in stroke patients.

Full description

Effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises with high intensity and duration. In this context, in addition to traditional treatments, many new treatment approaches have come up in recent years. Robot-assisted therapy (RAT) is one of these new treatment approaches. RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications. It is seen that robotic systems are very suitable for the patient to receive more intense and task-oriented motor training by integrating with other rehabilitation approaches. Considering the scarcity of studies on robotic hand therapy, it was seen that larger scale and long-term studies are needed. In this study, investigators aimed to investigate the effect of robotic hand therapy added to conventional rehabilitation on motor functions and quality of life in stroke patients. Patients will be evaluated pretreatment, posttreatment and 3 months later after treatment. Evaluation parameters consist of Brunnstrom Staging, Modified Ashworth Scale (MAS), Fugl Meyer Assessment of The Upper Extremity, Functional Independence Measure Scale (FIM) and ABILHAND Questionnaire, Stroke Impact Scale (SIS), Stroke-Specific Quality of Life Scale (SS-QOL) and SF-36 Quality of Life Questionnaire. We think that robot-assisted therapy will contribute to the improvement of hand functions and quality of life in stroke patients.

Enrollment: 50 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Unilateral stroke

Between 4 weeks and 6 months after stroke

health status was suitable for rehabilitation

who could understand commands with a mini mental test score of 15 and above

who had Brunnstrom grade 3 and below (≤3).

Exclusion criteria

Patients with persistent upper extremity pain on the hemiplegic side (VAS>40)

Patients with severe spasticity in the hand (MAS≥3)

Patients with contractures in the hand

Patients who had fractures or operations on the hemiplegic side 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 brain stem or cerebellar lesions

Patients with neglect or apraxia

Patients with severe visual impairment and severe depression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Robot Assisted Therapy Group

Experimental group

Description:

In addition to the conventional treatment for 60 minutes in the Robot asisted therapy (RAT) group, it was planned to perform robotic rehabilitation with a hand-finger robot \[Amadeo (Tyromotion, Graz, Austria)\] for 30 minutes, accompanied by a physiotherapist who is trained in the field of robotic rehabilitation and has at least 5 years of experience. For the purpose of conventional therapy, an exercise program consisting of 45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) accompanied by a physiotherapist experienced in stroke rehabilitation for at least 5 years, and neuromuscular therapy for the upper and lower extremities for 15 minutes.Electrical stimulation (NMES) application was planned. It was planned to apply a total of 60 sessions of treatment 5 days a week to both groups. They will be advised to continue the medical treatment they have been using during the treatment program.

Treatment:

Procedure: Robot assisted therapy

Conventional Therapy Group

Active Comparator group

Description:

45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological studies were performed in the presence of a physiotherapist experienced in stroke rehabilitation for at least 5 years.An exercise program consisting of exercises (Brunstroom exercises) and 15 minutes of NMES were planned. It was planned to apply a total of 60 sessions of treatment 5 days a week to both groups. They will be advised to continue the medical treatment they have been using during the treatment program.

Treatment:

Procedure: Conventional Therapy Group