NCT06199167

Brief Summary

Introduction: Musculoskeletal problems in the upper limb (UL) caused by nerve damage following Obstetric Brachial Plexus Injury (OBPI) and disorders affecting the use of the UL can limit activities of daily living (ADLs) and limit the child's participation in school and society. Method: Twenty-six children with OBPY aged between 6-17 years participated in the study and were randomised AOT and Photo Observation (PO) groups in equal numbers by stratified randomisation. In the 15-session treatment, a total of 18 ADL activities related to personal care, dressing, eating and preparation, transfer and mobilisation activities, reaching, and sports activities were studied with six exercises per session. The AOT group watched each ADL activity for two minutes through pre-prepared videos and then repeated the movement they watched for three minutes. The PO group observed the photographs taken from the video for two minutes and then practised the movement described for three minutes. The same sequence was continued for six exercises and one session was completed in approximately 30 minutes. Abilhand-Kids (AK), Seated Medicine Ball Throw (SMBT), Modified Push-up Test (MPT), Functional Reach Test (FRT), Lateral Reach Test (LRT), Brachial Plexus Outcome Measurement (BPOM), Gilbert and Raimondi Score (GRS), Box Block Test (BBT) were performed before and after the treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

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

May 12, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

December 28, 2023

Last Update Submit

January 9, 2024

Conditions

Keywords

Obstetric Brachial Plexus InjuryAction Observation TherapyUpper Limb FunctionVisual Motor Imagination

Outcome Measures

Primary Outcomes (5)

  • Abilhand Kids

    ABILHAND-Kids is a measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved

    5 weeks

  • Seated Medicine Ball Throw

    This test measures upper body (arm) strength and explosive power. By keeping the back in contact with the wall the strength of the arms only are tested.

    5 weeks

  • Modified Push-up Test

    The Modified Push-Up Test is used to measure upper body strength endurance and trunk stability. This variation, which uses a modified technique with a clap behind the back while in the 'down' position and a touch from one hand to the other in the 'up' position.

    5 weeks

  • Functional Reach Test

    Functional Reach Test (FRT) is the maximal distance one can reach forward beyond arm's length while maintaining a fixed standing position.

    5 weeks

  • Lateral Reach Test

    The LR Test measures postural stability in the medial-lateral direction by assessing the maximum distance an individual can reach laterally beyond arm's length at shoulder height, while maintaining a fixed base of support in the standing position

    5 weeks

Secondary Outcomes (3)

  • Brachial Plexus Outcome Measurement

    5 weeks

  • Gilbert and Raimondi Score

    5 weeks

  • Box Block Test

    5 weeks

Study Arms (2)

Action Observation Therapy

EXPERIMENTAL

The Action Observation Therapy group watched each ADL activity for two minutes through pre-prepared videos and then repeated the movement they watched for three minutes.

Behavioral: Action Observation Therapy

Photo Observation

EXPERIMENTAL

The Photo Observation group observed the photographs taken from the video for two minutes and then practised the movement described for three minutes.

Behavioral: Photo Observation

Interventions

The Action Observation Therapy group watched each ADL activity for two minutes through pre-prepared videos and then repeated the movement they watched for three minutes. In the 15-session treatment, a total of 18 ADL activities.

Action Observation Therapy

The Photo Observation group observed the photographs taken from the video for two minutes and then practised the movement described for three minutes. In the 15-session treatment, a total of 18 ADL activities.

Photo Observation

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being between the ages of 6-18
  • OBPY diagnosed in Type 1, Type 2a, Type 2b group according to Narakas classification system
  • Triceps brachii muscle strength above 3/5 in manual muscle strength assessment
  • Family and child agree to take part in the study

You may not qualify if:

  • History of upper extremity surgery and Botox in the last 6 months
  • Difficulty in understanding the commands given
  • Visual and hearing problems
  • Finding of shoulder dislocation
  • Orthopaedic problems associated with OBPY

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants did not know the other intervention and were not exposed to each other
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 10, 2024

Study Start

May 12, 2023

Primary Completion

October 30, 2023

Study Completion

December 20, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations