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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06095336
Other study ID # 2021/85
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 28, 2023
Est. completion date February 1, 2024

Study information

Verified date October 2023
Source Inonu University
Contact burak bugday
Phone 5357306877
Email burak.bugday@inonu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study was planned to investigate the effectiveness of home therapy method due to the difficulties experienced by caregivers of individuals with special needs in accessing physiotherapy and rehabilitation services for chronic neck and back pain.


Description:

Caring for a disabled child is a very difficult and long process for parents. In this process, mothers and fathers exert a lot of effort while caring for the child, carrying the child and playing an active role in its rehabilitation. For these reasons, it is reported that the physical health of mothers and fathers is negatively affected and they often experience waist and back pain. Telerehabilitation allows patients who cannot access rehabilitation due to geographical, economic or physical disabilities to benefit from rehabilitation services. The distance problem is especially valid in cases where people live far from the rehabilitation center, there are no rehabilitation professionals specialized in the relevant disease in the place of residence, when transfers are difficult due to mobility problems, and in cases where it is not possible or risky to go to the rehabilitation center due to epidemics, as is the case today. Telerehabilitation has the potential to overcome all these problems. The study was planned to investigate the effectiveness of home therapy method due to the difficulties experienced by caregivers of individuals with special needs in accessing physiotherapy and rehabilitation services for chronic neck and back pain.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date February 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - Being between 20-60 years old, - Being a special needs child caregiver, - Mechanical neck and back pain lasting 3 months or longer Exclusion Criteria: - Those who are caregivers of hearing and visually impaired children, - Having previously undergone surgery in the cervical region, - Patients with a history of inflammatory or infective arthritis in the cervical spine, - Congenital spinal cord anomaly, - history of malignancy, - Having neuropathic pain - Radiculopathy, myelopathy or other neurological disorders - Those with chronic lung disease - Vestibular disorders, - Those with a history of continuous drug use, - Individuals who have been involved in an exercise or physiotherapy program in the last 3 months, - He will not be able to read the scales and the evaluation parameters will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
telerehabilitation
The individuals included in the research will be divided into three groups. Group 1 (experiment): This is the exercise group followed by the telerehabilitation method. Group 2 (experiment): This is the group where traditional physical therapy methods will be applied. The 3rd group will be taken as the control group, there will be no intervention and they will be asked to continue their daily lives.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

References & Publications (2)

Hailey D, Roine R, Ohinmaa A, Dennett L. Evidence of benefit from telerehabilitation in routine care: a systematic review. J Telemed Telecare. 2011;17(6):281-7. doi: 10.1258/jtt.2011.101208. Epub 2011 Aug 15. — View Citation

Terzi R, Tan G. Musculoskeletal system pain and related factors in mothers of children with cerebral palsy. Agri. 2016 Jan;28(1):18-24. doi: 10.5505/agri.2015.74436. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Demographic information form The survey form prepared by the researcher in line with the literature includes information about the patients' name, surname, CV, family history, age, height, weight, occupation, dominant side, smoking and alcohol use, and additional symptoms. before treatment
Primary Qualitative Questions Form A form containing questions asking about the number of individuals with special needs that they care for, the time they spend with the individual with special needs on a daily basis, the presence of another child other than the individual with special needs that they care for, whether there is help at home, the GMFCS Score of the individuals being cared for, and whether physical, mental or both effects are at the same time. will be prepared and implemented. before treatment, after treatment, after 6 months
Primary Pain Assessment Visual Analog Scale (VAS) was used to determine the severity of pain in the cases. The beginning will be marked as 0 (no pain) and the end (unbearable pain) on a 10 centimeter (cm) horizontal line, and the subjects will be asked to make a mark on this horizontal line according to the degree of pain they feel. The marked point on the line will then be measured with the help of a ruler and recorded as the VAS value in cm. before treatment, after treatment, after 6 months
Primary Fatigue Assessment: The FACIT Scale is a measurement tool consisting of 13 statements that subjectively evaluates fatigue in the last week. The scale has a five-point Likert scale: "0 = not at all, 1 = very little, 2 = a little, 3 = quite a bit and 4 = very much." 11 items (1-6, 9-13) of the scale contain reverse expressions. Items 7 and 8 of the scale are calculated as straight. The scores that can be obtained from the scale vary between 0-52. A high total score of the scale indicates that the severity of fatigue is low. If the score obtained from the scale is 30 or less, it is reported that perceived fatigue is clinically severe. before treatment, after treatment, after 6 months
Primary Short Form-36 (Short Form-36, SF-36): It is a valid and frequently used measure to evaluate quality of life. It includes 36 questions in eight subscales: physical function, physical role limitation, emotional role limitation, body pain, social function, mental health, vitality, and general health. before treatment, after treatment, after 6 months
Secondary Bournemouth Neck Pain Survey: It will be used to evaluate individuals with neck pain in terms of pain severity, participation in family and social life, depression, anxiety, kinesiophobia and pain coping skills. Individuals will be asked to give points between 0 and 10 for a total of 7 questions. before treatment, after treatment, after 6 months
Secondary Caregiving Burden Scale: The Caregiving Burden Scale (CAÖ) is a 14-item scale. BYÖ's item scores are between 0-5. 0 means "Never", 1 means "Rarely", 2 means "Sometimes", 3 means "Often", and 4 means "Almost always". The evaluation of the ACO, in which all items are expressed plainly, is made on the basis of the total score. before treatment, after treatment, after 6 months
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