Telerehabilitation-Based Early Upper Extremity Training in Stroke Patients

NCT06261099 | Recruiting

• 1 other identifier: 037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic.

Conditions

Stroke, Acute

Keywords

telerehabilitation; Upper Extremity; rehabilitation; Proprioception

Outcome Measures

Primary Outcomes (5)

• Mini Mental Test

  It is used to evaluate the cognitive status of patients. It is a simple, short and valid test that is widely used in people with stroke. With this test, various cognitive functions of people such as orientation, recording memory, attention and calculation, recall and language are evaluated. The maximum score that can be obtained is 30. Getting a score of 24 or above indicates that the patient's cognitive functions are within normal limits.

  six weeks

• Fugl Meyer Motor Function Scale

  Motor performance is evaluated in stroke patients. Each item is given a score from 0 to 2, depending on performance: 2 points; complete detailing, 1 point; partial work of details, 0 points; It is given if details cannot be achieved. The maximum motor performance score for the upper extremity is 66 points.

  six weeks

• Laser-pointer Assisted Angle Reproduction Test

  It evaluates proprioceptive deviation in stroke patients. Shoulder flexion is measured three times at 45◦, 60◦ and 90◦, and upper extremity proprioception is evaluated by taking the average result of the three measurements.

  six weeks

• Modified Barthel Index

  Determines the functional adequacy, dependency level and rehabilitation services of stroke patients. Items on the scale are rated between 0 and 15 points in 5-point increments depending on the question. 0-20 points are considered fully dependent, 21-61 points are considered highly dependent, 62-90 points are considered moderately dependent, 91-99 points are considered mildly dependent, and 100 points are considered fully independent.

  six weeks

• Reaching Performance Scale

  It evaluates compensatory movements for upper extremity extension in stroke patients. Scores on items 1 to 5 are used to identify deficiencies in specific aspects of movement, with scores ranging from 0 to 18 being obtained depending on changing performance.

  six weeks

Study Arms (2)

Control Group

NO INTERVENTION

Exercises including upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group, 5 sessions per week for 6 weeks. Since the functional recovery of the upper extremity after stroke will be slow, the exercise program is planned to be 5 days a week due to the necessity of applying an intense exercise program in the early period. All patients will be asked to perform exercises under the supervision of a physiotherapist as a home program on other days of the week.

kontrol+ working group

EXPERIMENTAL

Upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group using the telerehabilitation method, which was applied to the control group in 5 sessions per week for 6 weeks. The telerehabilitation program will be carried out using an application that provides remote video access called Zoom. Since the functional recovery of the upper extremity after stroke will be slow, the exercise program is planned to be 5 days a week due to the necessity of applying an intense exercise program in the early period. All patients will be asked to perform exercises under the supervision of a physiotherapist as a home program on other days of the week.

Other: control + working group

Interventions

control + working group OTHER

Upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group using the telerehabilitation method, which was applied to in 5 sessions per week for 6 weeks.

kontrol+ working group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 30-65, with a history of stroke within the last month,
• Mini Mental Score ≥ 24, 1-10 after discharge. on the day,
• patients who can sit for at least 30 seconds, exhibit a hemiparetic condition, and are clinically stable

You may not qualify if:

• Flaccid hemiplegia detected by anamnesis and physical examination,
• Has spasticity in the upper extremity with a severity greater than 1+ according to the Modified Ashworth Scale,
• patients with severe dementia and dysfunction of the upper extremity joints due to a previous musculoskeletal disease

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (2)

Güler Ertuğrul

Kocaeli, İ̇zmi̇t, Turkey (Türkiye)

RECRUITING

Suleyman Demirel University

Isparta, Merkez, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Güler ERTUĞRUL

CONTACT

+90 531 950 05 90; gertugrul004@gmail.com

Mehmet DURAY

CONTACT

+90 506 473 11 65; mehmetduray@sdu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sealed envelopes will be prepared in advance for randomization and will be marked with numbers 1 and 2, indicating whether they are a study group or a control group. Randomization will be done by a third party unaware of the study content. Randomization order tracking will be done with sequentially numbered containers. Patients participating in the study will be blinded to which treatment group they will be included in.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc student, physiotherapist

Model Details: prospective double-blind, randomized controlled trial

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: February 8, 2024
• Primary Completion: February 27, 2025
• Study Completion: November 27, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)