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Not yet recruitingNCT06095336Updated Oct 23, 2023

Telerehabilitation and Conventional Physiotherapy Program for Caregivers of Individuals With Special Needs

An interventional study of telerehabilitation in Telerehabilitation and Neck Pain, sponsored by Inonu University. Not yet recruiting. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Inonu University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Telerehabilitation
  • Neck Pain

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Keywords

  • individual with special needs
  • back pain
03

In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's planned enrollment of 36 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Telereahabilitation arm

    The group receiving telerehabilitation will be given a video CD containing the exercise program that will be changed every 3 weeks, and in the first week of each change program, daily sessions will be held collectively via video conferencing under the supervision of a physiotherapist. In the first 3 weeks of the 12-week exercise program, neck joint movements, neck stretching exercises and posture exercises will be given. Between weeks 4-6, in addition to the exercises in the first 3 weeks, cervical and scapular stabilization exercises will be given in the following weeks. In the following weeks, between weeks 7-9, 4-way strengthening exercises will be included in the program in addition to the exercises performed in the previous weeks. Cervical and scapular stabilization exercises and strengthening exercises will be performed in the following weeks between weeks 10-12, Exercises will be done 10 repetitions 3 times a day.

    Other: telerehabilitation

  • Experimental
    conventional physiotherapy arm

    Superficial heat (infrared), "Transcutaneous Electrical Nerve Stimulation" (TENS), therapeutic ultrasound and Hotpack application will be applied to the traditional treatment group. The patients receive 20 sessions in total, 5 days a week and 1 session daily for 4 weeks; You will receive superficial heat (infrared), TENS, therapeutic US and Hotpack treatment. . Superficial heat infrared will be applied to the tissue for 20 minutes. Conventional TENS will be applied. Therapeutic US will be applied to the cervical and thoracic region with an ultrasound device for 5 minutes at 3mHz, 1W/cm² treatment dosage, in continuous mode. Hotpack application will be done for 20 minutes. At the end of the 20 sessions, a brochure containing video-supported exercises will be given to the patients in the first group and they will be asked to do it for 12 weeks without follow-up.

    Other: telerehabilitation

  • No intervention
    control arm

    The third group, the control group, will not receive any intervention and will be asked to continue their daily lives.

Interventions

  • Othertelerehabilitation

    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.

    Also known as: conventional physiotherapy, control

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: before treatment

  2. 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.

    Time frame: before treatment, after treatment, after 6 months

  3. 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.

    Time frame: before treatment, after treatment, after 6 months

  4. 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.

    Time frame: before treatment, after treatment, after 6 months

  5. 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.

    Time frame: before treatment, after treatment, after 6 months

Secondary outcomes

  1. 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.

    Time frame: before treatment, after treatment, after 6 months

  2. 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.

    Time frame: before treatment, after treatment, after 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 27225608 ↗
  • 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. PubMed 21844172 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06095336
Lead sponsor
Inonu University
Responsible party
Burak Buğday (lecturer, Inonu University) — Principal investigator
First posted
Oct 23, 2023
Start date
Oct 28, 2023 (estimated)
Primary completion
Jan 1, 2024 (estimated)
Completion
Feb 1, 2024 (estimated)
Last update
Oct 23, 2023

Study contacts

burak buğday
Contact
burak.bugday@inonu.edu.tr
5357306877
havva adlı
Contact
havva.adli@inonu.edu.tr
5369831133
burak buğday
principal investigator · Inonu University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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