Effects of the Action Observation Therapy and Robotic Rehabilitation on the Upper-Limb Motor Function in Stroke

NCT05590156 | Completed DMC

• 1 other identifier: 09.2022.649
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol will investigate the effects of action observation therapy and robotic rehabilitation on upper extremity motor functions in subacute stroke patients. Firstly, for this purpose, conventional rehabilitation approaches will take 60 minutes before both treatment methods in stroke patients. The upper-limb conventional rehabilitation program will be applied to all patients according to their individual needs (60x3x8 minutes/day/week). This program will consist of purposeful clinical exercises with a physiotherapist. After the conventional rehabilitation, one of the groups will receive action observation therapy, while the other will receive robotic rehabilitation. Both additional treatment methods will also be applied for 60 minutes. Treatment durations of both additional treatments are the same (60x3x8 minutes/day/week). Assessments will be made three times (Beginning, 4th week, 8th week).

Conditions

Stroke

Keywords

Robotic Rehabilitation; Action Observation Therapy; Upper Extremity; Motor Function

Outcome Measures

Primary Outcomes (6)

• Fugl Meyer Assessment for Upper Extremity

  This form is used to detect healing in the upper extremity.

  Baseline

• Fugl Meyer Assessment for Upper Extremity

  This form is used to detect healing in the upper extremity.

  End of the 4th week

• Fugl Meyer Assessment for Upper Extremity

  This form is used to detect healing in the upper extremity.

  End of the 8th week

• Wolf Motor Function Test

  This test is used for the level of motor function.

  Baseline

• Wolf Motor Function Test

  This test is used for the level of motor function.

  End of the 4th week

• Wolf Motor Function Test

  This test is used for the level of motor function.

  End of the 8th week

Secondary Outcomes (10)

• Demographic Data Form

  Baseline

• Functional Independence questionnaire

  Baseline

• Functional Independence questionnaire

  End of the 4th week

• Functional Independence questionnaire

  End of the 8th week

• The Stroke-Specific Quality of Life Scale (SS-QoL)

  Baseline

Study Arms (2)

Action Observation Therapy (AOT)

EXPERIMENTAL

AOT is a method based on the principle that the patient watches the movements of a healthy individual and then tries to imitate them. AOT consists of a monitoring-imitation cycle. A cycle consists of 3 minutes of observation, and 3 minutes of imitation. The intervention will consist of 10 cycles for simple functions. Complex movements will be applied by separating them into their components. The cycle time for each component is the same. Take for example, the cup-reaching function: The first component is the cup-reaching activity. The second component is the glass grip. One cycle will be completed on the first component (6 minutes), then one cycle will be completed for the second component (6 minutes) and one cycle (6 minutes) will be completed for the entire movement. Cycles will follow each other for 60 minutes. For the AOT, 31 different videos were prepared for the shoulder, elbow, and wrist. Applications will be made in the hospital under the supervision of a physiotherapist.

Procedure: Conventional Rehabilitation; Procedure: Action Observation Therapy (AOT)

Robotic Rehabilitation

EXPERIMENTAL

The robotic rehabilitation application will be performed with the ExoRehab X (HoustonBionics, Inc.) device. There is no engine to create any repulsive-pulling force in this device. It is a system that works entirely with the patient's active movement. Active movements of the shoulder, elbow, and wrist in all directions can be performed with the device. Motion is detected with the help of the device's censor, and the avatar moves on the screen. There are 10 different purposeful games embedded in the device. The device also allows resistance exercise thanks to resistance modules. Which joint will be trained will be determined according to the potential of the patient. For example, if programming will be done for the shoulder, elbow and wrist, the treatment time will be 20 minutes for each joint. Applications will be made in the hospital under the supervision of a physiotherapist.

Procedure: Conventional Rehabilitation; Device: Robotic Rehabilitation (ExoRehab X)

Interventions

Conventional Rehabilitation PROCEDURE

Conventional treatment for the upper extremity will be applied according to the patient's individual needs. A physiotherapist will apply this method in the clinic for 60 minutes. The duration of treatment is 60x3x8 minutes/day/week. Other methods will be applied in addition to the conventional treatment program.

Action Observation Therapy (AOT); Robotic Rehabilitation

Robotic Rehabilitation (ExoRehab X) DEVICE

Robotic Rehabilitation

Robotic Rehabilitation

Action Observation Therapy (AOT) PROCEDURE

Action Observation Therapy (AOT)

Action Observation Therapy (AOT)

Eligibility Criteria

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

You may qualify if:

• Between 18-80 aged
• Stroke history in last six months
• Mini-Mental Status Evaluation \>24 points,
• Having an Ability to sit independently,
• Presence of at least half of the range of motion of all joints for the upper extremity,
• Spasticity ≤ 2 according to the Modified Ashworth Scale,
• The Fugl-Meyer Assessment for Upper Extremity score between 20-60,
• Individuals without visual impairment,
• Individuals with normal communication and cooperation skills.

You may not qualify if:

• Having another neurological disease,
• Having any orthopedic problems that may affect the upper extremity,
• Taking neuropsychiatric treatment,
• Individuals who had a botox history or tendon surgery,
• Using neuroleptic drugs,
• Having an ataxia,
• Individuals who attended less than 80% of the total number of sessions.

Sponsors & Collaborators

• Emre Şenocak: lead

Study Sites (1)

Marmara University

Istanbul, 34083, 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

• Emre Şenocak, MSc

  Marmara University

  STUDY DIRECTOR

• Aysel Yildiz Ozer, PhD

  Marmara University

  STUDY CHAIR

• Elif Korkut, PhD

  Bağcılar Education and Research Hospital

  STUDY DIRECTOR

• Adem Aktürk, PhD

  İstanbul Gelişim University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 21, 2022
• Study Start: December 12, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)