Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05707052
Other study ID # REC/RCR&AHS/22/0230
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date March 22, 2023

Study information

Verified date January 2023
Source Riphah International University
Contact Imran Amjad, Phd
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date March 22, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 15 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Pakistan Idrees Hospital Sialkot Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT06142721 - Comparison of Walking Parameters Between Idiopathic Toe Walking and Independent Walking Diparetic Cerebral Palsy
Completed NCT05559346 - Investigation of the Effects of Diaphragm Exercises in Children With Cerebral Palsy N/A
Active, not recruiting NCT05946096 - Effects of Dynamic Surface Exercise Training on Trunk Control and Gross Motor Functions in Children With Diplegic Cerebral Palsy N/A
Not yet recruiting NCT06291974 - Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy
Completed NCT06233136 - Effect of Leg Pedalling Exercise From Inclined Position N/A
Recruiting NCT06047756 - Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic Cerebral Palsy N/A
Completed NCT05115695 - The Effect of Upper Extremity Strengthening on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy N/A
Not yet recruiting NCT05412485 - Gait Improvement After Increased Frequency of Robot-assisted Gait Training in Cerebral Palsy Children N/A
Completed NCT04467385 - Virtual Reality Training With Sensory Integration On The Gross Motor Functions Of Lower Limb N/A
Completed NCT04231227 - The Validity and Reliability of the Turkish Version of TASC and the Relationship Between SMC and Motor Functions
Completed NCT06234215 - Effect of Electrical Stimulation With Functional Task Training on Balance and Motor Abilities in Children With Diplegia N/A
Completed NCT04653363 - Evaluation of the Applicability and Reliability of the Three Meter Backwalk Test in Children With Cerebral Palsy (CP)
Completed NCT03373890 - Cerebral Palsy: Short-burst Interval Training N/A
Completed NCT04688424 - FES Assisted Cycling in Children With CP N/A