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

NCT ID: NCT05601115

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-06-01

Brief Summary

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.

Detailed 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.

Conditions

Stroke; Robot Assisted Therapy; Robotic Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robot Assisted Therapy Group

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.

Group Type: EXPERIMENTAL

Robot assisted therapy

Intervention Type: PROCEDURE

In addition to the conventional treatment for 60 minutes in the RYT 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

Conventional Therapy Group

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.

Group Type: ACTIVE_COMPARATOR

Conventional Therapy Group

Intervention Type: PROCEDURE

An exercise program consisting of 45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) and 15 minutes of NMES was planned, accompanied by a physiotherapist experienced for at least 5 years in stroke rehabilitation, in the conventional therapy group.

Interventions

Robot assisted therapy

In addition to the conventional treatment for 60 minutes in the RYT 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

Intervention Type: PROCEDURE

Conventional Therapy Group

An exercise program consisting of 45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) and 15 minutes of NMES was planned, accompanied by a physiotherapist experienced for at least 5 years in stroke rehabilitation, in the conventional therapy group.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

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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

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• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Sevda Adar

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SEVDA ADAR

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

Sevda Adar

Afyonkarahisar, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SASHR22

Identifier Type: -

Identifier Source: org_study_id