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

Primary Purpose

Cerebral Palsy Spastic Diplegia

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neck-Trunk Stabilization Exercises and conventional physical therapy
Bobath Therapy and conventional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy Spastic Diplegia focused on measuring Bobath; Cerebral palsy; Neck-Trunk Stabilization;

Eligibility Criteria

4 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Idrees HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neck-Trunk Stabilization exercises

Bobath Therapy

Arm Description

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.

trunk-pelvic-hip neutral alignment with anterior-posterior weight shifts on the ball, bilateral upper extremity abduction-traction for lateral weight shift, prone extension on the ball, forward weight shift for the trunk and hip extension and forward protective extension, diagonal weight shifts in flexion-rotation direction, lateral weight shift for simultaneous activation of flexors and extensors, bilateral shoulder flexion for latissimus dorsi elongation, pectoral elongation exercise for trunk extension, preparatory trunk activities (with continuous and/or intermittent compression and intermittent support), 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2023
Last Updated
January 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05707052
Brief Title
Neck-Trunk Stabilization Exercises and Bobath Therapy Spastic Diplegic Cerebral Palsy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
March 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy Spastic Diplegia
Keywords
Bobath; Cerebral palsy; Neck-Trunk Stabilization;

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neck-Trunk Stabilization exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Bobath Therapy
Arm Type
Experimental
Arm Description
trunk-pelvic-hip neutral alignment with anterior-posterior weight shifts on the ball, bilateral upper extremity abduction-traction for lateral weight shift, prone extension on the ball, forward weight shift for the trunk and hip extension and forward protective extension, diagonal weight shifts in flexion-rotation direction, lateral weight shift for simultaneous activation of flexors and extensors, bilateral shoulder flexion for latissimus dorsi elongation, pectoral elongation exercise for trunk extension, preparatory trunk activities (with continuous and/or intermittent compression and intermittent support), 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.
Intervention Type
Other
Intervention Name(s)
Neck-Trunk Stabilization Exercises and conventional physical therapy
Intervention Description
Neck-Trunk Stabilization Exercises along with conventional physical therapy in which stretching, strengthening, ROMs positioning and electrical stimulation are included.
Intervention Type
Other
Intervention Name(s)
Bobath Therapy and conventional physical therapy
Intervention Description
Bobath based exercises along with conventional physical therapy in which stretching, strengthening, ROMs positioning and electrical stimulation are included.
Primary Outcome Measure Information:
Title
Segmental Assessment of Trunk Control (SATCo)
Description
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.
Time Frame
4th week
Title
Manual Ability Classification System (MACS)
Description
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.
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Raza, MS(OMPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Idrees Hospital
City
Sialkot
State/Province
Punjab
ZIP/Postal Code
51300
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Raza, MsPT
Phone
03326099065
Email
araza.frahs@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Ayesha Zulfiqar, MsPT(NMPT)
First Name & Middle Initial & Last Name & Degree
Ali Raza, Ms(OMPT)

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34590804
Citation
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.
Results Reference
background
PubMed Identifier
34173063
Citation
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.
Results Reference
background
Citation
Desouzart G. Physiotherapy intervention according to the Bobath concept in a clinical case of cerebral palsy. Ortho Res Online J. 2018;3(4).
Results Reference
background
PubMed Identifier
28533628
Citation
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.
Results Reference
background
PubMed Identifier
27942155
Citation
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.
Results Reference
background

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

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