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

NCT05601115 | Completed

• 1 other identifier: SASHR22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Robot Assisted Therapy; Robotic Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Brunnstrom stage

  Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient was defined as 6 stages. According to this staging low stage; stage 1 (flask, the stage without voluntary movement), the highest stage was determined as stage 6 (stage with isolated joint movement). Hand, upper and lower limbs in Brunnstrom staging extremities are evaluated separately.

  5 minutes

• upper extremity spasticity assessment

  It was planned to evaluate spasticity with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in the direction of flexion and extension.

  5 minutes

• Fugl Meyer Upper Extremity Assessment Questionnaire wrist and hand assessment

  The Fugl-Meyer Upper Extremity Motor Rating Scale was developed to quantitatively evaluate sensorimotor recovery after stroke.Based on Brunnstrom's stages of motor recovery

  15 minutes

• ABILHAND Stroke Hand Function Questionnaire

  The ABILHAND Hand Questionnaire was developed in 1998 to measure patient-perceived dexterity. It contains 23 questions about how difficult the patient has to do the activities. impossible (0 points), difficult (1 point), easly (2 points) options is marked. The total score is 46.

  15 minutes

Secondary Outcomes (4)

• Functional Independence Scale

  20 minutes

• Stroke Impact Survey

  20 minutes

• Stroke Specific Quality of Life Scale: SSQOL

  30 minutes

• short form 36

  30 minutes

Study Arms (2)

Robot Assisted Therapy Group

EXPERIMENTAL

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.

Procedure: Robot assisted therapy

Conventional Therapy Group

ACTIVE COMPARATOR

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.

Procedure: Conventional Therapy Group

Interventions

Robot assisted therapy 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

Robot Assisted Therapy Group

Conventional Therapy Group 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.

Conventional Therapy Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Sevda Adar

Afyonkarahisar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• SEVDA ADAR

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: November 1, 2022
• Study Start: December 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

TU (1)