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NCT Number: NCT05590156

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

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, 34083, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Robotic Rehabilitation (ExoRehab X)

Device

Robotic Rehabilitation

Action Observation Therapy (AOT)

Procedure

Action Observation Therapy (AOT)

Primary outcomes

  1. Fugl Meyer Assessment for Upper Extremity

    Time frame: Baseline

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

  2. Fugl Meyer Assessment for Upper Extremity

    Time frame: End of the 4th week

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

  3. Fugl Meyer Assessment for Upper Extremity

    Time frame: End of the 8th week

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

  4. Wolf Motor Function Test

    Time frame: Baseline

    This test is used for the level of motor function.

  5. Wolf Motor Function Test

    Time frame: End of the 4th week

    This test is used for the level of motor function.

  6. Wolf Motor Function Test

    Time frame: End of the 8th week

    This test is used for the level of motor function.

Secondary outcomes

  1. Demographic Data Form

    Time frame: Baseline

    Informations about the patients

  2. Functional Independence questionnaire

    Time frame: Baseline

    This form helps determine an individual's level of independence.

  3. Functional Independence questionnaire

    Time frame: End of the 4th week

    This form helps determine an individual's level of independence.

  4. Functional Independence questionnaire

    Time frame: End of the 8th week

    This form helps determine an individual's level of independence.

  5. 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.

  6. 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.

  7. 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.

  8. Box and Block Test

    Time frame: Baseline

    This test is used to evaluate gross motor function of the upper extremity.

  9. Box and Block Test

    Time frame: End of the 4th week

    This test is used to evaluate gross motor function of the upper extremity.

  10. Box and Block Test

    Time frame: End of the 8th week

    This test is used to evaluate gross motor function of the upper extremity.

Sponsors and collaborators

Lead sponsor

Emre Şenocak

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2022
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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