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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Rehabilitation
Robotic Rehabilitation (ExoRehab X)
Action Observation Therapy (AOT)
Sponsored by
Emre Şenocak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Robotic Rehabilitation, Action Observation Therapy, Upper Extremity, Motor Function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Marmara UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Action Observation Therapy (AOT)

Robotic Rehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fugl Meyer Assessment for Upper Extremity
This form is used to detect healing in the upper extremity.
Fugl Meyer Assessment for Upper Extremity
This form is used to detect healing in the upper extremity.
Fugl Meyer Assessment for Upper Extremity
This form is used to detect healing in the upper extremity.
Wolf Motor Function Test
This test is used for the level of motor function.
Wolf Motor Function Test
This test is used for the level of motor function.
Wolf Motor Function Test
This test is used for the level of motor function.

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2022
Last Updated
March 13, 2023
Sponsor
Emre Şenocak
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1. Study Identification

Unique Protocol Identification Number
NCT05590156
Brief Title
Effects of the Action Observation Therapy and Robotic Rehabilitation on the Upper-Limb Motor Function in Stroke
Official Title
Can Action Observation Therapy be an Alternative to Robotic Rehabilitation to Improve Upper Extremity Functions in Stroke Patients? A Protocol of Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
December 12, 2024 (Anticipated)
Study Completion Date
December 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emre Şenocak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Robotic Rehabilitation, Action Observation Therapy, Upper Extremity, Motor Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Action Observation Therapy (AOT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Robotic Rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Robotic Rehabilitation (ExoRehab X)
Intervention Description
Robotic Rehabilitation
Intervention Type
Procedure
Intervention Name(s)
Action Observation Therapy (AOT)
Intervention Description
Action Observation Therapy (AOT)
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment for Upper Extremity
Description
This form is used to detect healing in the upper extremity.
Time Frame
Baseline
Title
Fugl Meyer Assessment for Upper Extremity
Description
This form is used to detect healing in the upper extremity.
Time Frame
End of the 4th week
Title
Fugl Meyer Assessment for Upper Extremity
Description
This form is used to detect healing in the upper extremity.
Time Frame
End of the 8th week
Title
Wolf Motor Function Test
Description
This test is used for the level of motor function.
Time Frame
Baseline
Title
Wolf Motor Function Test
Description
This test is used for the level of motor function.
Time Frame
End of the 4th week
Title
Wolf Motor Function Test
Description
This test is used for the level of motor function.
Time Frame
End of the 8th week
Secondary Outcome Measure Information:
Title
Demographic Data Form
Description
Informations about the patients
Time Frame
Baseline
Title
Functional Independence questionnaire
Description
This form helps determine an individual's level of independence.
Time Frame
Baseline
Title
Functional Independence questionnaire
Description
This form helps determine an individual's level of independence.
Time Frame
End of the 4th week
Title
Functional Independence questionnaire
Description
This form helps determine an individual's level of independence.
Time Frame
End of the 8th week
Title
The Stroke-Specific Quality of Life Scale (SS-QoL)
Description
This is a quality of life assessment scale specific to stroke patients. Individuals with a high quality of life also have a high score.
Time Frame
Baseline
Title
The Stroke-Specific Quality of Life Scale (SS-QoL)
Description
This is a quality of life assessment scale specific to stroke patients. Individuals with a high quality of life also have a high score.
Time Frame
End of the 4th week
Title
The Stroke-Specific Quality of Life Scale (SS-QoL)
Description
This is a quality of life assessment scale specific to stroke patients. Individuals with a high quality of life also have a high score.
Time Frame
End of the 8th week
Title
Box and Block Test
Description
This test is used to evaluate gross motor function of the upper extremity.
Time Frame
Baseline
Title
Box and Block Test
Description
This test is used to evaluate gross motor function of the upper extremity.
Time Frame
End of the 4th week
Title
Box and Block Test
Description
This test is used to evaluate gross motor function of the upper extremity.
Time Frame
End of the 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emre Şenocak, MSc
Phone
+905535695692
Email
emre.senocak@windowslive.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emre Şenocak, MSc
Organizational Affiliation
Marmara University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aysel Yildiz Ozer, PhD
Organizational Affiliation
Marmara University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elif Korkut, PhD
Organizational Affiliation
Bağcılar Education and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Adem Aktürk, PhD
Organizational Affiliation
İstanbul Gelişim University
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34083
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emre Şenocak, MSc
Phone
+905535695692
Email
emre.senocak@windowslive.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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