Muskuloskeletal DiseasesNCT06518811
The Effect of Telerehabilitation on Pain, Physical and Biopsychosocial Factors in Parent Carers
A study testing Video-Based Exercise Programme in people with Muskuloskeletal Diseases, run by Ilke KARA at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effects of asynchronous video-based exercises on pain, disability, anxiety, care burden and quality of life in parent carers of children with special needs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Muskuloskeletal Diseases
- What is being tested?
- Video-Based Exercise Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2022to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The individual must be the primary caregiver of a child with physical, mental, or a combination of both disabilities.
- The individual must have been in this role for a minimum of six months.
- Willing to participate in the study.
- Able to read and write in Turkish.
Who cannot join
- A clear cognitive or language disability
- A recent deterioration of family relationships or the presence of factors affecting them (separation of parents, divorce, etc.)
- A history of cardiac or pulmonary disease or diseases (uncontrolled hypertension, arrhythmia, COPD, asthma, etc.), neurological disease, orthopaedic or rheumatological disease (rheumatoid arthritis, ankylosing spondylitis, arthrosis, etc.)
- A disease that may prevent exercise or that has resulted in surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Özel Gereksinimli Çocuğu Olan Ebeveynlerde Telerehabilitasyon Uygulamasının Ağrı, Yetersizlik, Anksiyete ve Depresyon, Fiziksel Aktivite Seviyesi ve Yaşam Kalitesi Üzerine Etkisi
This study aimed to investigate the effects of asynchronous video-based exercises on pain, disability, anxiety, care burden and quality of life in parent carers of children with special needs.
Read the detailed description
This study aimed to investigate the effects of asynchronous video-based exercises on pain, disability, anxiety, care burden and quality of life in parent carers of children with special needs.
Parents carers were invited to participate in the study through a variety of channels, including printed posters, corporate social media posts, phone calls through local administrations and non-governmental associations. At the information meeting, the participants were informed about the benefits of ergonomic training for activities of daily living. Also handbooks containing the same information were distributed. Demographic data were collected, and questionnaires were used to assess pain, disability, physical activity levels, care burden, and quality of life.
Individuals who met the inclusion criteria were randomly assigned to either the exercise group or the control group. The exercise group was informed of the details of the study methodology, technology literacy, and tablet usage. In order to ascertain an appropriate exercise programme for each individual, the researchers identified musculoskeletal problems of participants. The exercise programme comprised videos of relaxation, postural control and muscle strengthening exercises, which were recorded by research team and uploaded to the tablets. Subsequently, the participants were informed of the safety precautions during the exercise programme at home and the ergonomic placement of the tablets.
The eight-week exercise programme required participants to perform the exercises on a regular basis, three times per week, with the assistance of guided videos. Additionally, they were required to record their performance in written exercise diaries, which were distributed to them.
Exercises also supported by online calls made by the researchers once a week. In each interview, the participants were reminded of the next scheduled online interview activity. At the end of the eight-week, final evaluations were obtained through face-to-face interviews.
- Conditions
- Muskuloskeletal Diseases
- Being tested
- Video-Based Exercise Programme
- Keywords
- Telerehabilitaton, Video-Based Exercises, Parent Carer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based Exercise ProgrammeOther
The asynchronous video-based telerehabilitation programme had a duration of eight weeks. The participants were instructed to perform the exercises on a regular basis, three days a week, with a time interval of 24 hours between each session. The exercises were to be performed using the instructional videos and recorded in the exercise diaries provided. The participants were used exercise balls and resistance bands distributed by the researchers according to exercise programme.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The asynchronous video-based telerehabilitation programme had a duration of eight weeks. The exercise group participants were instructed to perform the exercises on a regular basis, three days a week, with a time interval of 24 hours between each session. The exercises were to be performed using the instructional videos and recorded in the exercise diaries provided. Receives: Other: Video-Based Exercise Programme |
| Control group | No intervention | Control group participants were informed about the benefits of ergonomic training for activities of daily living. Also handbooks containing the same information were distributed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Pain intensity is measured using a visual analogue scale (VAS). The level of pain felt at rest and during activity is recorded on a 10-centimetre scale. A score of zero indicates no pain and '10' indicates unbearable pain.
Measured: 8 weeks
Scandinavian Musculoskeletal Questionnaire
The Scandinavian Musculoskeletal Questionnaire was used to assess musculoskeletal problems. The questionnaire employs a pictorial representation of the body, comprising images of the neck, shoulders, back, elbows, wrists/hands, waist, hips/thighs, knees, and ankles/feet, to elicit responses pertaining to musculoskeletal complaints. For each body part, three questions are posed, even in the absence of any perceived issues. For each specified area, participants are asked whether they have experienced a physical problem in the preceding 12 months, 1 month, and in the last 7 days. They are also asked whether they have fallen behind in their academic or professional activities as a result of this problem. Each question on the questionnaire is included in the evaluation, with a value of '1' assigned to a positive response and '0' assigned to a negative response.
Measured: 8 weeks
Secondary outcomes (6)
Zarit Scale of Caregiver Burden
The level of care burden was evaluated using the Zarit Scale of Caregiver Burden. The scale comprises a total of 22 questions, including items that examine the physical, mental, social and economic aspects of the caregiver role. The scale items are scored on a four-point Likert scale, with the options "0=Never", "1=Rarely", "2=Sometimes", "3=Frequently" and "4=Almost always". The total score is obtained by summing the scores given to each item. The total score obtained from the scale is indicative of the degree of care burden. A total score of 0-20 is indicative of a 'little or no care burden', a score of 21-40 is indicative of a 'light care burden', a score of 41-60 is indicative of a 'moderate care burden', and a score of 61-88 is indicative of a 'heavy care burden'.
Measured: 8 weeks
Neck Disability Index
The Neck Disability Index assesses the severity of neck pain, symptoms, duration and disability in the activities listed in each item. Each item has 5 options and is scored from 0 to 4 points. The total score for neck pain is 36 points. If patients do not drive, the total score is calculated using 32 points.
Measured: 8 weeks
Oswestry Disability Index
The Oswestry Disability Index has 10 sections including pain intensity, ability to perform daily tasks, heavy lifting, walking, sitting, standing, sleeping, sexual life, social life and travel. The participant is asked to select the statement that best describes their condition from 6 options. The patient is scored on a range of 0-20 points if their daily life is minimally affected, 20-40 points if it is moderate, 40-60 points if it is severe, 60-80 points if it is completely restricted and 80-100 points if they are bedridden.
Measured: 8 weeks
International Physical Activity Level Questionnaire-Short Form
Physical activity was assessed using the International Physical Activity Level Questionnaire-Short Form (IPAQ). It consists of seven questions and provides information on time spent in walking, moderate-intensity and vigorous-intensity activities and time spent sitting during the past week.
Measured: 8 weeks
Adult Carer Quality of Life Questionnaire
Quality of life was assessed using the Adult Carer Quality of Life Questionnaire, a 40-item tool developed specifically for adult carers, which provides the opportunity to assess quality of life in 8 different domains: caregiving, care preferences, caregiving stress, financial issues, personal development, appreciation, caregiving ability and carer satisfaction.
Measured: 8 weeks
Hospital Anxiety and Depression Scale
Levels of anxiety and depression were assessed using the Hospital Anxiety and Depression Scale. Out of a total of 14 questions, seven assess anxiety and seven assess depression.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start12 Dec 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muskuloskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilke KARA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ilke KARA, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518811
- Sponsor's protocol ID
- DEU-FTR-IK-03
- Status last verified
- Aug 2025
- First submitted
- 19 Jul 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Özel Gereksinimli Çocuğu Olan Ebeveynlerde Telerehabilitasyon Uygulamasının Ağrı, Yetersizlik, Anksiyete ve Depresyon, Fiziksel Aktivite Seviyesi ve Yaşam Kalitesi Üzerine Etkisi
- ClinicalTrials.gov ID
- NCT06518811
- Acronym / sponsor ID
- DEU-FTR-IK-03
- Conditions
- Muskuloskeletal Diseases
- Keywords
- Telerehabilitaton, Video-Based Exercises, Parent Carer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ilke KARAUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to investigate the effects of asynchronous video-based exercises on pain, disability, anxiety, care burden and quality of life in parent carers of children with special needs.
Detailed description
This study aimed to investigate the effects of asynchronous video-based exercises on pain, disability, anxiety, care burden and quality of life in parent carers of children with special needs.
Parents carers were invited to participate in the study through a variety of channels, including printed posters, corporate social media posts, phone calls through local administrations and non-governmental associations. At the information meeting, the participants were informed about the benefits of ergonomic training for activities of daily living. Also handbooks containing the same information were distributed. Demographic data were collected, and questionnaires were used to assess pain, disability, physical activity levels, care burden, and quality of life.
Individuals who met the inclusion criteria were randomly assigned to either the exercise group or the control group. The exercise group was informed of the details of the study methodology, technology literacy, and tablet usage. In order to ascertain an appropriate exercise programme for each individual, the researchers identified musculoskeletal problems of participants. The exercise programme comprised videos of relaxation, postural control and muscle strengthening exercises, which were recorded by research team and uploaded to the tablets. Subsequently, the participants were informed of the safety precautions during the exercise programme at home and the ergonomic placement of the tablets.
The eight-week exercise programme required participants to perform the exercises on a regular basis, three times per week, with the assistance of guided videos. Additionally, they were required to record their performance in written exercise diaries, which were distributed to them.
Exercises also supported by online calls made by the researchers once a week. In each interview, the participants were reminded of the next scheduled online interview activity. At the end of the eight-week, final evaluations were obtained through face-to-face interviews.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Video-Based Exercise ProgrammeThe asynchronous video-based telerehabilitation programme had a duration of eight weeks. The exercise group participants were instructed to perform the exercises on a regular basis, three days a week, with a time interval of 24 hours between each session. The exercises were to be performed using the instructional videos and recorded in the exercise diaries provided. |
| Control group | No intervention | –Control group participants were informed about the benefits of ergonomic training for activities of daily living. Also handbooks containing the same information were distributed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The individual must be the primary caregiver of a child with physical, mental, or a combination of both disabilities.
- The individual must have been in this role for a minimum of six months.
- Willing to participate in the study.
- Able to read and write in Turkish.
Key exclusion criteria (4 listed)
- A clear cognitive or language disability
- A recent deterioration of family relationships or the presence of factors affecting them (separation of parents, divorce, etc.)
- A history of cardiac or pulmonary disease or diseases (uncontrolled hypertension, arrhythmia, COPD, asthma, etc.), neurological disease, orthopaedic or rheumatological disease (rheumatoid arthritis, ankylosing spondylitis, arthrosis, etc.)
- A disease that may prevent exercise or that has resulted in surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Based Exercise ProgrammeThe asynchronous video-based telerehabilitation programme had a duration of eight weeks. The participants were instructed to perform the exercises on a regular basis, three days a week, with a time interval of 24 hours between each session. The exercises were to be performed using the instructional videos and recorded in the exercise diaries provided. The participants were used exercise balls and resistance bands distributed by the researchers according to exercise programme. | Other | Exercise group |
Primary outcome
Visual analogue scale
Time frame: 8 weeks
Pain intensity is measured using a visual analogue scale (VAS). The level of pain felt at rest and during activity is recorded on a 10-centimetre scale. A score of zero indicates no pain and '10' indicates unbearable pain.
Scandinavian Musculoskeletal Questionnaire
Time frame: 8 weeks
The Scandinavian Musculoskeletal Questionnaire was used to assess musculoskeletal problems. The questionnaire employs a pictorial representation of the body, comprising images of the neck, shoulders, back, elbows, wrists/hands, waist, hips/thighs, knees, and ankles/feet, to elicit responses pertaining to musculoskeletal complaints. For each body part, three questions are posed, even in the absence of any perceived issues. For each specified area, participants are asked whether they have experienced a physical problem in the preceding 12 months, 1 month, and in the last 7 days. They are also asked whether they have fallen behind in their academic or professional activities as a result of this problem. Each question on the questionnaire is included in the evaluation, with a value of '1' assigned to a positive response and '0' assigned to a negative response.
6 secondary outcomes
Zarit Scale of Caregiver Burden
Time frame: 8 weeks
Neck Disability Index
Time frame: 8 weeks
Oswestry Disability Index
Time frame: 8 weeks
International Physical Activity Level Questionnaire-Short Form
Time frame: 8 weeks
Adult Carer Quality of Life Questionnaire
Time frame: 8 weeks
Hospital Anxiety and Depression Scale
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Muskuloskeletal Diseases
Not yet recruiting
Virtual Reality-based Rehabilitation for Traumatic Hand and Wrist Injuries
Wrist Injury, Hand and Upper Limb Trauma
RecruitingObservational study
Proton MRI of MSK Disorders
Muskuloskeletal Diseases, Healthy
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Active, not recruitingObservational study
Cortical Changes After Upper Limb Immobilization Measured by Electroencephalography
Wrist Injury, Hand and Upper Limb Trauma
Not yet recruitingPhase 2
Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity
Anthracycline-induced Cardiotoxicity, Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Based Exercise Programme in people with Muskuloskeletal Diseases, run by Ilke KARA at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.