The Effectiveness of Telerehabilitation in Stroke Patients

Stroke Clinical Trial

Official title:

The Effectiveness of Modified-Constraint Induced Movement Therapy Based Telerehabilitation in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128461
• Other study ID #: 1-Stroke-CIMT-Telerehab.
• Status: Completed
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: October 20, 2022

Study information

• Verified date: July 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stroke, according to the definition of the World Health Organization (WHO); It is a syndrome characterized by a rapid settlement of signs and symptoms of focal loss of cerebral function without a cause other than vascular causes. As it is known, it is important for patients to regain functional skills in the upper extremities after stroke. Modified-Constraint Induced Movement Therapy (m-CIMT) is a versatile neurorehabilitation technique that aims to improve motor function in the hemiparetic upper extremity and increase its use in daily life activities. However, as in the Covid-19 pandemic, patients cannot always reach rehabilitation services. In such cases, telerehabilitation is a treatment option. There are a limited number of studies in which m-CIMT is applied according to the principle of telerehabilitation, which has become a necessity, especially due to the Covid-19 pandemic. Therefore, the aim of this study is to examine the effects of m-CIMT on upper extremity motor functions in stroke patients.

Description:

This study is a randomized controlled study. The patients will be randomly divided into two groups as exercise and control. Patients in both groups will be given lower-upper extremity exercises and gait training exercises selected according to the Bobath approach as a home program consisting of 10 exercises to be applied 5 days a week for 3 weeks. All patients will perform the same exercises. In addition, the exercise group will receive Modified-Constraint Induced Movement Therapy (m-CIMT) based telerehabilitation via video conferencing 5 days a week for 3 weeks. Patients in the m-CIMT group will be asked to restrict the movements of their less affected hands by using mitt for 5 hours a day/ 5 days a week for 3 weeks while the patients are awake. Evaluations for both groups will be made by a physiotherapist blinded to the study twice, at the beginning and 3 weeks later. As outcome measures functional performance, hand strength, activities of daily living and quality of life will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 20, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years of age

• Being diagnosed with stroke for the first time by a doctor

• Having been diagnosed with stroke at least 1 month ago

• Mini-Mental Test Score more than or equal 24

• In the upper extremities; Starting from the angle of full flexion, wrist extension of at least 20° or more, thumb extension or abduction of at least 10°, minimum extension of all other fingers at the metacarpophalangeal and interphalangeal joints

• Having less than 2.5 points in the pre-treatment evaluation from both parts of MAG-28

• Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.

• Absence of severe pain to affect the treatment

• Absence of severe spasticity to affect the treatment (spasticity in any joint of the upper extremity = 2 according to the Modified Ashworth Scale)

Exclusion Criteria:

• Any orthopedic, vision, hearing or perception problems that may affect the research results

• Having an additional neurological, cardiovascular, pulmonary or hormonal disorder that would prevent participation in the study.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Exercise
M-CIMT-based telerehabilitation will be implemented.
• Home program
Lower and upper extremity exercises and gait training exercises selected according to the Bobath approach will be given as a home program consisting of 10 same exercises.

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper extremity motor ability-Baseline	Wolf Motor Function Test	Assessment will be conducted before the intervention.
Primary	Upper extremity motor ability-Post intervention	Wolf Motor Function Test	Assessment will be conducted immediately after the intervention.
Primary	Upper extremity motor function-Baseline	The Fugl-Meyer Assessment of the Upper Extremity	Assessment will be conducted before the intervention.
Primary	Upper extremity motor function-Post intervention	The Fugl-Meyer Assessment of the Upper Extremity	Assessment will be conducted immediately after the intervention.
Primary	Activities of daily living related to the upper extremity-Baseline	Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.	Assessment will be conducted before the intervention.
Primary	Activities of daily living related to the upper extremity-Post intervention	Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.	Assessment will be conducted immediately after the intervention.
Primary	Voluntary movement and mobility-Baseline	Stroke Rehabilitation Assessment of Movement (STREAM)	Assessment will be conducted before the intervention.
Primary	Voluntary movement and mobility-Post intervention	Stroke Rehabilitation Assessment of Movement (STREAM)	Assessment will be conducted immediately after the intervention.
Secondary	Isometric hand strength-Baseline	J-Tech™	Assessment will be conducted before the intervention.
Secondary	Isometric hand strength-Post intervention	J-Tech™	Assessment will be conducted immediately after the intervention.
Secondary	Isometric pinch strength-Baseline	Baseline® pinch meter	Assessment will be conducted before the intervention.
Secondary	Isometric pinch strength-Post intervention	Baseline® pinch meter	Assessment will be conducted immediately after the intervention.
Secondary	manual dexterity performance-Baseline	nine-hole peg test (9-HTP)	Assessment will be conducted before the intervention.
Secondary	manual dexterity performance-Post intervention	nine-hole peg test (9-HTP)	Assessment will be conducted immediately after the intervention.
Secondary	level of independence in activities of daily living-Baseline	Functional Independence Measure	Assessment will be conducted before the intervention.
Secondary	level of independence in activities of daily living-Post intervention	Functional Independence Measure	Assessment will be conducted immediately after the intervention.

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