NCT06007833

Brief Summary

The aim of this study was to investigate the effects of physical therapy and rehabilitation applications on the hip and defined functional parameters in children with developmental hip dysplasia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 10, 2023

Last Update Submit

August 18, 2023

Conditions

Keywords

DysplasiaHip subluxationDislocationRehabilitation

Outcome Measures

Primary Outcomes (1)

  • The Evaluation of Trunk Control

    Trunk Control Measurement Scale, This scale, which is applied to evaluate trunk control, consists of 2 sub-headings as static sitting balance and dynamic sitting balance. The trunk control measurement scale includes a total of 15 items evaluating trunk control in children. Individuals; without back support, feet are in full contact with the ground, and hips and knees are seated in 90º flexion. In the static sitting balance subgroup (items 1-5), the patient's performance in maintaining trunk stabilization while the upper and lower extremities are in motion is evaluated. It consists of dynamic sitting balance parameters (item 6-15), selective movement control (item 6-12) and dynamic reaching subscale (item 13-15). Functional reach, which is a sub-parameter of dynamic sitting balance, is an important parameter in evaluating balance in children. Scoring of this scale varies between 0-58; A higher score indicates better trunk control.

    baseline and week 8

Secondary Outcomes (8)

  • The Evaluation of the Endurance of the Spinal Stability Muscles

    baseline and week 8

  • The Evaluation of the Strength of the Spinal Stability Muscles

    baseline and week 8

  • The Evaluation with Radiological Imaging of Hip Parameters

    baseline and week 8

  • The Assessment of Aerobic Capacity

    baseline and week 8

  • The Evaluation of Anaerobic Capacity

    baseline and week 8

  • +3 more secondary outcomes

Study Arms (2)

physical therapy and rehabilitation program in addition to conservative treatment

EXPERIMENTAL

Orthoses and positioning will be applied to the experimental group as a conservative treatment, following post-surgical plastering. In addition, they will receive a physical therapy and rehabilitation program

Behavioral: Physical Therapy and Rehabilitation Modalities

Conventional Group

ACTIVE COMPARATOR

As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning will be applied

Behavioral: Conventional Group

Interventions

In the experimental group, the subjects who were taken to the physical therapy modality in addition to conventional therapy. Total, each session was performed for 60 minutes, 8 weeks, 3 days a week, under the supervision of a physiotherapist, while the other days, the family member performed 3 times a day, each movement for 3 sets, 10-15 repetitions, for a total of 60 minutes. A rest interval of less than 2 minutes was given between each set. By making use of heat modalities before starting the exercises, the elongation ability of the warmed tense structure was increased and the risk of damage in stretching exercises was reduced. The cold application was applied to the soft tissues in the extended position for 1-2 minutes with a cold pack, as the application of cold immediately after the stretching would ensure the preservation of the range of motion. Progress in the exercise program; adjusted for strength, endurance, flexibility, balance and functionality parameters.

physical therapy and rehabilitation program in addition to conservative treatment

As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning was applied.

Conventional Group

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old,
  • Diagnosed with developmental hip dysplasia,
  • Have not undergone any foot surgery,
  • Not having any neurological or rheumatological disease,
  • Having sufficient cooperation to understand and correctly apply the tests,
  • Patients with informed consent from their families were included.

You may not qualify if:

  • Having neurological problems,
  • Meningomyelocele (diagnosed with Spina Bifida),
  • Mental retardation and uncooperative,
  • Children with inflammation, spasticity, spina bifida, arthrocentesis,
  • Down syndrome-related dislocation,
  • Children who could not obtain informed consent from their families were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityDevelopmental Dysplasia of the HipJoint Dislocations

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

BehaviorHip DislocationJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Elisa Calisgan, PhD

    Inonu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Çalışgan, PhD

CONTACT

Betül Akyol, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants didn't know taking which exercise treatment methods.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental, Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Investigation of the Effects of Physical Therapy and Rehabilitation Applications on the Hip and Defined Functional Parameters in Children with Developmental Hip Dysplasia

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 23, 2023

Study Start

September 1, 2023

Primary Completion

October 30, 2023

Study Completion

November 30, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations