The Effectiveness of Telerehabilitation in Stroke Patients

NCT ID: NCT05128461

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-22
• Study Completion Date: 2022-10-20

Brief 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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exercise Group

The group will receive modified-Constraint Induced Movement Therapy via telerehabilitation and a home exercise program.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

M-CIMT-based telerehabilitation will be implemented.

Home program

Intervention Type: OTHER

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.

Control group

The group only will be given a home exercise program.

Group Type: ACTIVE_COMPARATOR

Home program

Intervention Type: OTHER

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.

Interventions

Exercise

M-CIMT-based telerehabilitation will be implemented.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Fettah Saygılı

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fettah SAYGILI, PT, M.Sc.

Role: STUDY_CHAIR

Research Assistant

Arzu Güçlü-Gündüz, PT, PhD.

Role: STUDY_DIRECTOR

Professor

Locations

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Related Links

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7502810/

Related info

Other Identifiers

1-Stroke-CIMT-Telerehab.

Identifier Type: -

Identifier Source: org_study_id