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

Emre Şenocak

Status: Completed

Conditions: Stroke

Treatments: Procedure: Conventional Rehabilitation; Device: Robotic Rehabilitation (ExoRehab X); Procedure: Action Observation Therapy (AOT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05590156

09.2022.649

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Action Observation Therapy (AOT)

Experimental group

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.

Treatment:

Procedure: Action Observation Therapy (AOT)

Procedure: Conventional Rehabilitation

Robotic Rehabilitation

Experimental group

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.

Treatment:

Device: Robotic Rehabilitation (ExoRehab X)

Procedure: Conventional Rehabilitation