NCT06518811

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

July 19, 2024

Last Update Submit

August 18, 2025

Conditions

Keywords

TelerehabilitatonVideo-Based ExercisesParent Carer

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    8 weeks

Secondary Outcomes (6)

  • Zarit Scale of Caregiver Burden

    8 weeks

  • Neck Disability Index

    8 weeks

  • Oswestry Disability Index

    8 weeks

  • International Physical Activity Level Questionnaire-Short Form

    8 weeks

  • Adult Carer Quality of Life Questionnaire

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Exercise group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35330, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Eligible individuals will be randomly allocated to either the exercise group or the control group. Participants will be blinded to their group assignment.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 24, 2024

Study Start

December 12, 2022

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations