search
Back to results

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

Primary Purpose

Telerehabilitation, Neck Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
telerehabilitation
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telerehabilitation focused on measuring individual with special needs, back pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Telereahabilitation arm

    conventional physiotherapy arm

    control arm

    Arm Description

    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.

    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.

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    September 20, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Inonu University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06095336
    Brief Title
    Telerehabilitation and Conventional Physiotherapy Program for Caregivers of Individuals With Special Needs
    Official Title
    Comparison of the Effectiveness of Telerehabilitation and Conventional Physiotherapy Program in Chronic Neck and Back Pain Seen in Caregivers of Individuals With Special Needs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 28, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Inonu University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Telerehabilitation, Neck Pain
    Keywords
    individual with special needs, back pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    In the study, which was planned as a randomized controlled study, participants were randomly divided into 3 groups.
    Masking
    Participant
    Masking Description
    Participants in the study did not know the group they belonged to.
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Telereahabilitation arm
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    conventional physiotherapy arm
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control arm
    Arm Type
    No Intervention
    Arm Description
    The third group, the control group, will not receive any intervention and will be asked to continue their daily lives.
    Intervention Type
    Other
    Intervention Name(s)
    telerehabilitation
    Other Intervention Name(s)
    conventional physiotherapy, control
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Demographic information form
    Description
    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
    Title
    Qualitative Questions Form
    Description
    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
    Title
    Pain Assessment
    Description
    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
    Title
    Fatigue Assessment:
    Description
    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
    Title
    Short Form-36 (Short Form-36, SF-36):
    Description
    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 Outcome Measure Information:
    Title
    Bournemouth Neck Pain Survey:
    Description
    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
    Title
    Caregiving Burden Scale:
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    burak buğday
    Phone
    5357306877
    Email
    burak.bugday@inonu.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    havva adlı
    Phone
    5369831133
    Email
    havva.adli@inonu.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    burak buğday
    Organizational Affiliation
    Inonu University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27225608
    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.
    Results Reference
    background
    PubMed Identifier
    21844172
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/21844172/
    Description
    pubmed

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs