Clinical trial NCT05590156: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Robotic Rehabilitation
Action Observation Therapy
Upper Extremity
Motor Function
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fugl Meyer Assessment for Upper Extremity
timeFrame: Baseline
measure: Fugl Meyer Assessment for Upper Extremity
timeFrame: End of the 4th week
measure: Fugl Meyer Assessment for Upper Extremity
timeFrame: End of the 8th week
measure: Wolf Motor Function Test
timeFrame: Baseline
measure: Wolf Motor Function Test
timeFrame: End of the 4th week
measure: Wolf Motor Function Test
timeFrame: End of the 8th week
Secondary outcomes:
measure: Demographic Data Form
timeFrame: Baseline
measure: Functional Independence questionnaire
timeFrame: Baseline
measure: Functional Independence questionnaire
timeFrame: End of the 4th week
measure: Functional Independence questionnaire
timeFrame: End of the 8th week
measure: The Stroke-Specific Quality of Life Scale (SS-QoL)
timeFrame: Baseline
measure: The Stroke-Specific Quality of Life Scale (SS-QoL)
timeFrame: End of the 4th week
measure: The Stroke-Specific Quality of Life Scale (SS-QoL)
timeFrame: End of the 8th week
measure: Box and Block Test
timeFrame: Baseline
measure: Box and Block Test
timeFrame: End of the 4th week
measure: Box and Block Test
timeFrame: End of the 8th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Emre Şenocak, MSc
role: STUDY_DIRECTOR
affiliation: Marmara University
name: Aysel Yildiz Ozer, PhD
role: STUDY_CHAIR
affiliation: Bağcılar Education and Research Hospital
name: Elif Korkut, PhD
role: STUDY_DIRECTOR
affiliation: İstanbul Gelişim University
name: Adem Aktürk, PhD
role: STUDY_DIRECTOR
References: