NCT06443398

Brief Summary

The purpose of this study was to assess pain (rest, activity, and night pain using the Visual Analog Scale), disability (neck using the Neck Disability Index; lumbar using the Oswestry Disability Index), and curvature (cervical, thoracic, and lumbar using the Spinal Mouse) in primary caregivers of children with cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

October 1, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

May 30, 2024

Last Update Submit

September 28, 2024

Conditions

Keywords

Primary CaregiversPainDisability

Outcome Measures

Primary Outcomes (4)

  • Life Quality

    Parents' quality of life was measured using the Nottingham Health Profile. The scale has two parts. 0 represents the best health status, 100 the worst. Score on the scale and health status have an inverse relationship. As the score increases, the health status deteriorates.

    16 week

  • Disability

    Functional problems related to the neck were assessed using the Neck Disability Index. The scale has 10 items. There are 6 options in each item and each option is scored between 0 and 5 depending on the severity of the limitation. Although the total score of the survey varies between 0 and 50, a higher score indicates an increase in limitation.

    16 week

  • Disability

    Oswestry Disability Index was used to determine the degree of disability. The scale consists of a total of 10 items measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleeping, travel and pain degree. Each item is rated between 0-5. As the total score increases, the disability level increases. The maximum score is 50 points; Between 31 and 50 points is considered severe, between 11 and 30 points is considered moderate, and between 1 and 10 points is considered mild.

    16 week

  • Spine

    Spine evaluation was performed with a spinal mouse device. The device is a computer-aided electromagnetic device that can be held by hand and used to measure spinal mobility in various postures.

    16 week

Secondary Outcomes (3)

  • Socio-demographic Form

    16 week

  • Pain Intensity

    16 week

  • Gross Motor Function Classification

    16 week

Study Arms (2)

Control Group

Primary caregivers with healthy children between the ages of 0-18 were included.

Other: There is no intervention in the study

Study Group

Primary caregivers who had a child diagnosed with Cerebral Palsy between the ages of 0-18 and met the inclusion criteria were included.

Other: There is no intervention in the study

Interventions

There is no intervention in the study

Control GroupStudy Group

Eligibility Criteria

Age25 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

It was conducted with caregivers of children with Cerebral Palsy who were receiving physiotherapy at Kırşehir Training and Research Hospital Physical Therapy and Rehabilitation Center and who met the exclusion-inclusion criteria.

You may qualify if:

  • Primary caregiver between the ages of 25-54
  • Has a child diagnosed with Cerebral Palsy between the ages of 0-18
  • Does not have inflammatory pain
  • Without pain originating from abdominal-pelvic organs
  • Volunteer caregivers were included

You may not qualify if:

  • Having acute fracture and malignancy
  • Had a surgical operation (related to spine disorders)
  • Having a care burden for more than one disabled individual
  • Caregivers with chronic illnesses (such as neurological, psychological disorders) were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center

Kırşehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyPain

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Lecturer

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 5, 2024

Study Start

January 31, 2024

Primary Completion

September 20, 2024

Study Completion

September 25, 2024

Last Updated

October 1, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations