The Effectiveness of Telerehabilitation in Stroke Patients

NCT05128461 | Completed

• 1 other identifier: 1-Stroke-CIMT-Telerehab.
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Telerehabilitation; modified-Constraint Induced Movement Therapy; Upper Extremity

Outcome Measures

Primary Outcomes (8)

• Upper extremity motor ability-Baseline

  Wolf Motor Function Test

  Assessment will be conducted before the intervention.

• Upper extremity motor ability-Post intervention

  Wolf Motor Function Test

  Assessment will be conducted immediately after the intervention.

• Upper extremity motor function-Baseline

  The Fugl-Meyer Assessment of the Upper Extremity

  Assessment will be conducted before the intervention.

• Upper extremity motor function-Post intervention

  The Fugl-Meyer Assessment of the Upper Extremity

  Assessment will be conducted immediately after the intervention.

• 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.

• 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.

• Voluntary movement and mobility-Baseline

  Stroke Rehabilitation Assessment of Movement (STREAM)

  Assessment will be conducted before the intervention.

• Voluntary movement and mobility-Post intervention

  Stroke Rehabilitation Assessment of Movement (STREAM)

  Assessment will be conducted immediately after the intervention.

Secondary Outcomes (8)

• Isometric hand strength-Baseline

  Assessment will be conducted before the intervention.

• Isometric hand strength-Post intervention

  Assessment will be conducted immediately after the intervention.

• Isometric pinch strength-Baseline

  Assessment will be conducted before the intervention.

• Isometric pinch strength-Post intervention

  Assessment will be conducted immediately after the intervention.

• manual dexterity performance-Baseline

  Assessment will be conducted before the intervention.

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Other: Exercise; Other: Home program

Control group

ACTIVE COMPARATOR

The group only will be given a home exercise program.

Other: Home program

Interventions

Exercise OTHER

M-CIMT-based telerehabilitation will be implemented.

Exercise Group

Home program 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; Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

Related Links

• Related info

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fettah SAYGILI, PT, M.Sc.

  Research Assistant

  STUDY CHAIR

• Arzu Güçlü-Gündüz, PT, PhD.

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups as exercise group and control group

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 22, 2021
• Study Start: November 22, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 20, 2022
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)