NCT05707052

Brief Summary

Physiotherapy is widely used in the treatment of children with cerebral palsy. This study is conducted to identify the most appropriate physiotherapy approach. The purpose of the study is to compare two physical rehabilitation strategies i.e., Neck-trunk stabilization exercises and Bobath therapy, to investigate their effectiveness on trunk control and upper limb function. The aims of treatment are to influence muscle tone and improve postural alignment by specific handling technique.

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
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 22, 2023

Last Update Submit

January 22, 2023

Conditions

Cerebral Palsy Spastic Diplegia

Keywords

Bobath; Cerebral palsy; Neck-Trunk Stabilization;

Outcome Measures

Primary Outcomes (2)

  • Segmental Assessment of Trunk Control (SATCo)

    Changes from baseline SATCo provides a systematic method of assessing discrete levels of trunk control in children with motor disabilities. The SATCo determines the topmost (most cephalo) segment at which control of the upright posture is poor or not demonstrated i.e. is currently being learned for each of static, active and reactive control.

    4th week

  • Manual Ability Classification System (MACS)

    Changes from baseline MACS as been used to classify how children with cerebral palsy use their hands when handling objects in daily activities.it is designed to reflect the typical manual performance of child. The ability of children from 4 - 18 years old with cerebral palsy to handle objects in everyday activities can be categorized into 5 levels.

    4th week

Study Arms (2)

Neck-Trunk Stabilization exercises

EXPERIMENTAL

First neck and trunk exercise involved lifting the head in a modified bridge exercise position so that lower abdominal muscles contracted when the neck was bent, thereby activating the neck flexor muscle and the lower abdominal muscles simultaneously. Second exercise involved pushing the neck backward in supine position to activate the erector muscles of the neck and the upper thoracic vertebrae through the extension of the muscles of the back of the neck. Third exercise activated the deep abdominal muscles in bridge exercise positions so that the participants would experience the posterior inclined movement of the pelvis. Keep each posture for 10 seconds at a time and repeat 10 times with a rest interval of 3 seconds per each.

Other: Neck-Trunk Stabilization Exercises and conventional physical therapy

Bobath Therapy

EXPERIMENTAL

1. trunk-pelvic-hip neutral alignment with anterior-posterior weight shifts on the ball, 2. bilateral upper extremity abduction-traction for lateral weight shift, 3. prone extension on the ball, 4. forward weight shift for the trunk and hip extension and forward protective extension, 5. diagonal weight shifts in flexion-rotation direction, 6. lateral weight shift for simultaneous activation of flexors and extensors, 7. bilateral shoulder flexion for latissimus dorsi elongation, 8. pectoral elongation exercise for trunk extension, 9. preparatory trunk activities (with continuous and/or intermittent compression and intermittent support), 10. positioning and holding of the head-trunk Keep each posture for 10 seconds at a time with a rest interval of 3 seconds per each.

Other: Bobath Therapy and conventional physical therapy

Interventions

Neck-Trunk Stabilization Exercises and conventional physical therapyOTHER

Neck-Trunk Stabilization Exercises along with conventional physical therapy in which stretching, strengthening, ROMs positioning and electrical stimulation are included.

Neck-Trunk Stabilization exercises
Bobath Therapy and conventional physical therapyOTHER

Bobath based exercises along with conventional physical therapy in which stretching, strengthening, ROMs positioning and electrical stimulation are included.

Bobath Therapy

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with spastic diplegic cerebral palsy
  • Children with score of GMFCS \[2\] \[3\] \[4\] levels(2, 16).
  • Signed consent form from parents/guardians.

You may not qualify if:

  • Children with visual impairments
  • Children with major auditory impairments
  • Children with previous orthopedic surgery and Botulium toxin-A injection at least for 6 months
  • Children having pharmacological intervention for the inhibition of spasticity
  • Contractures
  • Uncontrolled seizures
  • Focal spasticity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Idrees Hospital

Sialkot, Punjab Province, 51300, Pakistan

RECRUITING

Related Publications (5)

  • Ejraei N, Ozer AY, Aydogdu O, Turkdogan D, Polat MG. The effect of neck-trunk stabilization exercises in cerebral palsy: randomized controlled trial. Minerva Pediatr (Torino). 2021 Sep 30. doi: 10.23736/S2724-5276.21.06206-6. Online ahead of print.

    PMID: 34590804BACKGROUND

  • Acar G, Ejraei N, Turkdogan D, Enver N, Ozturk G, Aktas G. The Effects of Neurodevelopmental Therapy on Feeding and Swallowing Activities in Children with Cerebral Palsy. Dysphagia. 2022 Aug;37(4):800-811. doi: 10.1007/s00455-021-10329-w. Epub 2021 Jun 25.

    PMID: 34173063BACKGROUND

  • Desouzart G. Physiotherapy intervention according to the Bobath concept in a clinical case of cerebral palsy. Ortho Res Online J. 2018;3(4).

    BACKGROUND

  • Shin JW, Song GB, Ko J. The effects of neck and trunk stabilization exercises on cerebral palsy children's static and dynamic trunk balance: case series. J Phys Ther Sci. 2017 Apr;29(4):771-774. doi: 10.1589/jpts.29.771. Epub 2017 Apr 20.

    PMID: 28533628BACKGROUND

  • Shin JW, Song GB. The effects of neck and trunk stabilization exercises on upper limb and visuoperceptual function in children with cerebral palsy. J Phys Ther Sci. 2016 Nov;28(11):3232-3235. doi: 10.1589/jpts.28.3232. Epub 2016 Nov 29.

    PMID: 27942155BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ali Raza, MS(OMPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2023

First Posted

January 31, 2023

Study Start

January 1, 2023

Primary Completion

March 15, 2023

Study Completion

March 22, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)