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

April 18, 2024 updated by: Emre Şenocak

Can Action Observation Therapy be an Alternative to Robotic Rehabilitation to Improve Upper Extremity Functions in Stroke Patients? A Protocol of Randomized Controlled Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomization: The online randomization software (www.randomizer.org) will be used for the study. After randomization, patients will be divided into two groups (AOT group, Robotic group)

Blinding: Due to the nature of the study, patient-practitioner blinding is not possible. But an independent expert will perform the statistical analysis, and single-blind will be provided.

Estimating Sample Size: Gpower 3.1.9.7 software was used for sample size calculation. To calculate the effect size, the study of Lima and Christofoletti was taken as a reference, and the effect size was calculated as 1.29. The alpha error was accepted as 5% and the power of the study was 80%. Accordingly, considering that there may be missing data in the study, it was planned to include a minimum of 30 stroke patients.

Statistical Analysis: Statistical Package for the Social Sciences (SPSS v11.5) program will be used for analysis. Whether the data is normally distributed or not will be questioned by the Shapiro-Wilks test and histogram curves. When the data are normally distributed, Independent Sample T-test will be used for comparisons between groups, and Paired-Sample T-test will be used for comparisons within groups. When the data do not show normal distribution, Mann-Whitney U Test will be used for intergroup comparisons and Wilcoxon Signed Rank Test will be used for in-group comparisons.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34083
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Action Observation Therapy (AOT)

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
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.
Procedure: Action Observation Therapy (AOT)
Action Observation Therapy (AOT)
Experimental: Robotic Rehabilitation

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
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.
Device: Robotic Rehabilitation (ExoRehab X)
Robotic Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl Meyer Assessment for Upper Extremity
Time Frame: Baseline
This form is used to detect healing in the upper extremity.
Baseline
Fugl Meyer Assessment for Upper Extremity
Time Frame: End of the 4th week
This form is used to detect healing in the upper extremity.
End of the 4th week
Fugl Meyer Assessment for Upper Extremity
Time Frame: End of the 8th week
This form is used to detect healing in the upper extremity.
End of the 8th week
Wolf Motor Function Test
Time Frame: Baseline
This test is used for the level of motor function.
Baseline
Wolf Motor Function Test
Time Frame: End of the 4th week
This test is used for the level of motor function.
End of the 4th week
Wolf Motor Function Test
Time Frame: End of the 8th week
This test is used for the level of motor function.
End of the 8th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Data Form
Time Frame: Baseline
Informations about the patients
Baseline
Functional Independence questionnaire
Time Frame: Baseline
This form helps determine an individual's level of independence.
Baseline
Functional Independence questionnaire
Time Frame: End of the 4th week
This form helps determine an individual's level of independence.
End of the 4th week
Functional Independence questionnaire
Time Frame: End of the 8th week
This form helps determine an individual's level of independence.
End of the 8th week
The Stroke-Specific Quality of Life Scale (SS-QoL)
Time Frame: Baseline
This is a quality of life assessment scale specific to stroke patients. Individuals with a high quality of life also have a high score.
Baseline
The Stroke-Specific Quality of Life Scale (SS-QoL)
Time Frame: End of the 4th week
This is a quality of life assessment scale specific to stroke patients. Individuals with a high quality of life also have a high score.
End of the 4th week
The Stroke-Specific Quality of Life Scale (SS-QoL)
Time Frame: End of the 8th week
This is a quality of life assessment scale specific to stroke patients. Individuals with a high quality of life also have a high score.
End of the 8th week
Box and Block Test
Time Frame: Baseline
This test is used to evaluate gross motor function of the upper extremity.
Baseline
Box and Block Test
Time Frame: End of the 4th week
This test is used to evaluate gross motor function of the upper extremity.
End of the 4th week
Box and Block Test
Time Frame: End of the 8th week
This test is used to evaluate gross motor function of the upper extremity.
End of the 8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emre Şenocak

Investigators

  • Study Director: Emre Şenocak, MSc, Marmara University
  • Study Chair: Aysel Yildiz Ozer, PhD, Marmara University
  • Study Director: Elif Korkut, PhD, Bağcılar Education and Research Hospital
  • Study Director: Adem Aktürk, PhD, Istanbul Gelisim University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Actual)

December 12, 2023

Study Completion (Actual)

December 12, 2023

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2022.649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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