CClinicalTrials.gg
Status unknownNCT05707052Updated Jan 31, 2023

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

An interventional study of Neck-Trunk Stabilization Exercises and conventional physical therapy and Bobath Therapy and conventional physical therapy in Cerebral Palsy Spastic Diplegia, sponsored by Riphah International University. Status unknown at 1 site in Pakistan. Open to participants aged 4 Years to 15 Years. Per ClinicalTrials.gov, last updated 2023-01-31.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
4 Years to 15 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy Spastic Diplegia

Keywords

  • Bobath; Cerebral palsy; Neck-Trunk Stabilization;
03

In context

Muscle Spasticity

703 studies on the registry are indexed under Muscle Spasticity; 148 are open to participants now.

This study's planned enrollment of 44 is above the median of 36 across 524 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherNeck-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.

  • OtherBobath Therapy and conventional physical therapy

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4th week

  2. 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.

    Time frame: 4th week

07

Study locations

1 of 1 sites recruiting
  • Idrees Hospital
    Sialkot, Punjab 51300, Pakistan
    • Ali Raza, MsPT · Contact · araza.frahs@riphah.edu.pk · 03326099065
    • Ayesha Zulfiqar, MsPT(NMPT) · Principal investigator
    • Ali Raza, Ms(OMPT) · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34590804 ↗
  • 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. PubMed 34173063 ↗
  • Desouzart G. Physiotherapy intervention according to the Bobath concept in a clinical case of cerebral palsy. Ortho Res Online J. 2018;3(4).
  • 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. PubMed 28533628 ↗
  • 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. PubMed 27942155 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05707052
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jan 31, 2023
Start date
Jan 1, 2023
Primary completion
Mar 15, 2023 (estimated)
Completion
Mar 22, 2023 (estimated)
Last update
Jan 31, 2023

Study contacts

Imran Amjad, Phd
Contact
imran.amjad@riphah.edu.pk
03324390125
Ali Raza, MS(OMPT)
principal investigator · Riphah International University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion