CClinicalTrials.gg
CompletedNCT05751122Updated Jul 25, 2023

Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Cerebral Palsy

An interventional study of Dynamic flex cast with neurodevelopmental treatment and Rigid Ankle foot Orthosis with neurodevelopmental treatment in Cerebral Palsy, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2023-07-25.

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
3 Years to 8 Years
Sex
All
01

Study summary

The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy.

Read the detailed description

The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy. Combination of Dynamic flex cast with neurodevelopmental treatment will be a novel potential treatment to improve gross motor functions in cerebral palsy. We shall try to fill the gaps of previous studies. It will help in facilitating children to perform their activities, restoring normal ranges and treatment of spasticity in cerebral palsy.

02

Conditions studied

  • Cerebral Palsy

Keywords

  • Ankle joint
  • Cerebral Palsy
  • Spasticity
  • Dynamic cast
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 134 are open to participants now.

This study's enrollment of 60 is above the median of 30 across 538 interventional studies indexed under Paralysis.

Browse Paralysis 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
3 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children with cerebral palsy
  • Age 3-8 years
  • Spastic diplegic/ hemiplegic CP
  • Ankle dorsiflexion 5-10 degrees
  • GMFCS level 1-3
  • Modified Ashworth's scale level 1+ - 3

Exclusion criteria

Exclusion Criteria:

  • Congenital foot deformities
  • Cognitive impairments
  • Secondary orthopedic, auditory and severe visual impairments
  • Unwilling patients or parents
  • Recent surgical interventions
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Dynamic flex cast with neurodevelopmental Group

    Dynamic flex cast with neurodevelopmental treatment

    Other: Dynamic flex cast with neurodevelopmental treatment

  • Active comparator
    Rigid Ankle foot Orthosis with neurodevelopmental Group

    Rigid Ankle foot Orthosis with neurodevelopmental treatment

    Other: Rigid Ankle foot Orthosis with neurodevelopmental treatment

Interventions

  • OtherDynamic flex cast with neurodevelopmental treatment

    Neurodevelopmental therapy in combination with dynamic flex cast to treat experimental group. Three times a week, 1 hour session per day. Dynamic flex casting is casting which manipulate bone alignment and maintains range of motion or sustained stretch. Casting will be changed weekly for 3 months. Neuro developmental approach is individualized treatment which is attuned to each child's specific problems, aims and goals. Key elements in NDT are: facilitation (using sensory inputs to improve motor performance), management of compensatory motor behavior, and an overall management strategy (a 24-hour interdisciplinary management approach) NDT involves task specific postures and movements.

  • OtherRigid Ankle foot Orthosis with neurodevelopmental treatment

    Rigid ankle foot orthosis will be applied to ankle joint at the start of intervention. Neurodevelopmental treatment will be applied to both groups with protocol; Three times a week, 1 hour session per day. Assessment on 1st day,6th week and 12th week

06

What researchers measure

Primary outcomes

  1. Gross Motor Function Measure-88

    The original GMFM has 88 items each scored on a 4-point ordinal scale of 0 to 3, where 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes \< 10% activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of activity); 3 indicates that the child completes the task (100%); and NT indicates that the child was not tested. The 88 items are grouped into five dimensions: 1) lying and rolling, 2) sitting, 3) crawling and kneeling, 4) standing, and 5) walking, running and jumping. Reliability with intraclass correlation coeffcient greater than .98 with 0.965--.994 95% confidence interval.

    Time frame: 12 weeks

  2. Clinical Gait Assessment Scale

    It is used to assess gait deviation. Temporal distance factors including velocity, cadence, stride length, stride width will be assessed.

    Time frame: 12 weeks

07

Study locations

1 site
  • Chal foundation, Bacha Khan Medical Complex
    Swābi, KPK 23430, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

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

Registry details

Key details

Study ID
NCT05751122
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Mar 2, 2023
Start date
Feb 25, 2023
Primary completion
Jul 15, 2023
Completion
Jul 15, 2023
Last update
Jul 25, 2023

Study contacts

Abrish Abbasi, MS-NMPT
principal investigator · Riphah International University

Oversight

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

Not currently enrolling

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

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