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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05590156
• Other study ID #: 09.2022.649
• Status: Completed
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: April 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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

Procedure:
• Action Observation Therapy (AOT)
Action Observation Therapy (AOT)

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Emre Senocak

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment for Upper Extremity	This form is used to detect healing in the upper extremity.	Baseline
Primary	Fugl Meyer Assessment for Upper Extremity	This form is used to detect healing in the upper extremity.	End of the 4th week
Primary	Fugl Meyer Assessment for Upper Extremity	This form is used to detect healing in the upper extremity.	End of the 8th week
Primary	Wolf Motor Function Test	This test is used for the level of motor function.	Baseline
Primary	Wolf Motor Function Test	This test is used for the level of motor function.	End of the 4th week
Primary	Wolf Motor Function Test	This test is used for the level of motor function.	End of the 8th week
Secondary	Demographic Data Form	Informations about the patients	Baseline
Secondary	Functional Independence questionnaire	This form helps determine an individual's level of independence.	Baseline
Secondary	Functional Independence questionnaire	This form helps determine an individual's level of independence.	End of the 4th week
Secondary	Functional Independence questionnaire	This form helps determine an individual's level of independence.	End of the 8th week
Secondary	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.	Baseline
Secondary	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.	End of the 4th week
Secondary	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.	End of the 8th week
Secondary	Box and Block Test	This test is used to evaluate gross motor function of the upper extremity.	Baseline
Secondary	Box and Block Test	This test is used to evaluate gross motor function of the upper extremity.	End of the 4th week
Secondary	Box and Block Test	This test is used to evaluate gross motor function of the upper extremity.	End of the 8th week