Robot-Assisted Therapy in Chronic Stroke Patients

NCT06692829 | Not Yet Recruiting

• 1 other identifier: SAROBOT2
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Considering the paucity of studies on robotic hand therapy, larger-scale and long-term follow-up studies are needed. The aim in this study is to demonstrate the effectiveness of robot-assisted hand therapy in patients with chronic stroke and to compare this effectiveness in patients with different Brunnstrom stages.

Conditions

Stroke; Hemiplegia

Keywords

stroke; hemiplegia; robotic rehabilitation; hand function

Outcome Measures

Primary Outcomes (4)

• Brunnstrom Staging

  is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient is defined as 6 stages. According to this staging, the lowest stage is stage 1 (flaccid, no voluntary movement stage), and the highest stage is stage 6 (isolated joint movement stage). In the Brunnstrom staging, the hand, upper extremity and lower extremity are evaluated separately.

  Before treatment (T0) At the end of the treatment (10. week) (T1)

• Modified Ashworth Scale

  Spasticity was planned to be evaluated with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0 indicates no increase in muscle tone, and 4 indicates that the extremity is rigid in the flexion and extension directions.

  Before treatment (T0) At the end of the treatment (10. week) (T1)

• Fugl Meyer Upper Extremity Assessment Questionnaire

  The Fugl-Meyer Upper Extremity Motor Assessment Scale (FMUE Scale) was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom\'s stages of motor recovery. The FMUE Scale consists of 33 items, each scored from 0 to 2, where 0 = cannot perform, 1 = partially performs, and 2 = fully performs. The total score is 66.

  Before treatment (T0) At the end of the treatment (10. week) (T1)

• ABILHAND Stroke Hand Function Questionnaire

  ABILHAND Hand Questionnaire was developed in 1998 to measure the hand skill perceived by the patient. It contains 23 questions about how much difficulty the patient has in performing the activities. One of the options impossible (0 points), difficult (1 point), easy (2 points) is marked. The total score is 46.

  Before treatment (T0) At the end of the treatment (10. week) (T1)

Secondary Outcomes (3)

• Mini Mental Test

  Before treatment (T0) At the end of the treatment (10. week) (T1)

• Stroke Impact Survey

  Before treatment (T0) At the end of the treatment (10. week) (T1)

• Stroke Specific Quality of Life Scale (SSQOL)

  Before treatment (T0) At the end of the treatment (10. week) (T1)

Study Arms (2)

Conventional Therapy

ACTIVE COMPARATOR

It was planned for the conventional therapy group to receive an exercise program consisting of 45 minutes of active, passive range of motion exercises and strengthening exercises, accompanied by a physiotherapist with at least 5 years of experience in stroke rehabilitation. A total of 20 treatment sessions will be applied 2 days a week.

Procedure: conventional rehabilitation

Robot Assisted Therapy

EXPERIMENTAL

In addition to conventional therapy, the robotic therapy group was planned to receive robotic rehabilitation with a hand-finger robot \[Amadeo (Tyromotion, Graz, Austria)\] for 45 minutes, accompanied by a physiotherapist trained in robotic rehabilitation and with at least 5 years of experience. A total of 20 treatment sessions will be applied 2 days a week.

Procedure: robotic rehabilitation; Procedure: conventional rehabilitation

Interventions

robotic rehabilitation PROCEDURE

In addition to conventional therapy, the robotic therapy group was planned to receive robotic rehabilitation with a hand-finger robot \[Amadeo (Tyromotion, Graz, Austria)\] for 45 minutes, accompanied by a physiotherapist trained in robotic rehabilitation and with at least 5 years of experience. A total of 20 treatment sessions will be applied 2 days a week.

Robot Assisted Therapy

conventional rehabilitation PROCEDURE

It was planned for the conventional therapy group to receive an exercise program consisting of 45 minutes of active, passive range of motion exercises and strengthening exercises, accompanied by a physiotherapist with at least 5 years of experience in stroke rehabilitation. A total of 20 treatment sessions will be applied 2 days a week.

Conventional Therapy; Robot Assisted Therapy

Eligibility Criteria

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

You may qualify if:

• who were 3 months post-CVA
• whose health status was suitable for rehabilitation
• who could understand commands with a mini mental test score of 15 and above.

You may not qualify if:

• Patients with persistent upper extremity pain on the hemiplegic side (VAS\>40)
• severe spasticity in the hand (MAS≥3)
• contracture in the hand
• fracture or surgery on the hemiplegic side within the last 6 months
• botulinum toxin injection into the upper extremity within the last 6 months
• skin ulcers
• brainstem or cerebellar lesions
• neglect or apraxia
• severe visual defects
• severe depression

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

SEVDA ADAR

CONTACT

+902722463335; drsevdaadar@gmail.com

Study Design

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

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: November 18, 2024
• Study Start: December 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11