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Cerebral Palsy Spastic DiplegiaNCT05707052

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

A study testing Neck-Trunk Stabilization Exercises and conventional physical therapy and Bobath Therapy and conventional physical therapy in people with Cerebral Palsy Spastic Diplegia, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 4 to 15 years
Conditions the study is for
Cerebral Palsy Spastic Diplegia
What is being tested?
Neck-Trunk Stabilization Exercises and conventional physical therapy and Bobath Therapy and conventional physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
1 Jan 2023to 22 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Imran Amjad, Phd contact

03324390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting

  • Idrees Hospital

    Sialkot, Punjab Province, 51300

    Ali Raza, MsPT, 03326099065, araza.frahs@riphah.edu.pk

    Ayesha Zulfiqar, MsPT(NMPT)

    Recruiting

Other trials in Pakistan

About this study

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

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.

Being tested
Neck-Trunk Stabilization Exercises and conventional physical therapy, Bobath Therapy and conventional physical therapy
Keywords
Bobath; Cerebral palsy; Neck-Trunk Stabilization;
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT05707052
Study groupRoleWhat they receive
Neck-Trunk Stabilization exercisesExperimentalFirst 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.
Receives: Other: Neck-Trunk Stabilization Exercises and conventional physical therapy
Bobath TherapyExperimental1. 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.
Receives: Other: Bobath Therapy and conventional physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2023
  2. Study start1 Jan 2023
  3. Primary completion15 Mar 2023 (estimated)
  4. Study completion22 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05707052
Sponsor's protocol ID
REC/RCR&AHS/22/0230
Status last verified
Jan 2023
First submitted
22 Jan 2023
Last updated
31 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Neck-Trunk Stabilization Exercises and conventional physical therapy and Bobath Therapy and conventional physical therapy in people with Cerebral Palsy Spastic Diplegia, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Segmental Assessment of Trunk Control (SATCo) (time frame: 4th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05707052, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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