Neck-Trunk Stabilization Exercises and Bobath Therapy Spastic Diplegic Cerebral Palsy

January 22, 2023 updated by: Riphah International University

Comparative Effects of Neck-Trunk Stabilization Exercises and Bobath Therapy on Trunk Control and Upper Limb Function in Children With Spastic Diplegic Cerebral Palsy: A Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be a Randomized Clinical Trial conducted at the physiotherapy outpatient clinic of the tertiary care hospital in Sialkot, Idrees Hospital. Following the approval of the BASR, the study will be completed within six months. The sample will be taken using a non-probability convenient sampling technique, and the sample will be randomly divided into two groups. A sample size of 44 patients will be taken in this study. There will be two groups. Both groups will receive conventional therapy consisting of stretching, strengthening, range-of-motion exercises, positioning, and electrical stimulation. Group A: This group will receive Neck-Trunk Stabilization exercises. Group B: This group will receive Bobath therapy. The total intervention protocol will be given for six weeks' duration, with three sessions per week of about 45 minutes each. Outcome measures tools will be Segmental Assessment of Trunk Control (SATCo) and Manual Ability Classification System (MACS). Children with spastic diplegic cerebral palsy will be measured at baseline and after 6 weeks.

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sialkot, Punjab, Pakistan, 51300
        • Recruiting
        • Idrees Hospital
        • Contact:
        • Principal Investigator:
          • Ayesha Zulfiqar, MsPT(NMPT)
        • Sub-Investigator:
          • Ali Raza, Ms(OMPT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Neck-Trunk Stabilization exercises
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
Neck-Trunk Stabilization Exercises along with conventional physical therapy in which stretching, strengthening, ROMs positioning and electrical stimulation are included.
EXPERIMENTAL: Bobath Therapy
  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
Bobath based exercises along with conventional physical therapy in which stretching, strengthening, ROMs positioning and electrical stimulation are included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Segmental Assessment of Trunk Control (SATCo)
Time Frame: 4th week
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)
Time Frame: 4th week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Ali Raza, MS(OMPT), Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2023

Primary Completion (ANTICIPATED)

March 15, 2023

Study Completion (ANTICIPATED)

March 22, 2023

Study Registration Dates

First Submitted

January 22, 2023

First Submitted That Met QC Criteria

January 22, 2023

First Posted (ACTUAL)

January 31, 2023

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 22, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/22/0230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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