NCT05751122

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 25, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

February 20, 2023

Last Update Submit

July 23, 2023

Conditions

Cerebral Palsy

Keywords

Ankle jointCerebral PalsySpasticityDynamic cast

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 weeks

  • Clinical Gait Assessment Scale

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

    12 weeks

Study Arms (2)

Dynamic flex cast with neurodevelopmental Group

EXPERIMENTAL

Dynamic flex cast with neurodevelopmental treatment

Other: Dynamic flex cast with neurodevelopmental treatment

Rigid Ankle foot Orthosis with neurodevelopmental Group

ACTIVE COMPARATOR

Rigid Ankle foot Orthosis with neurodevelopmental treatment

Other: Rigid Ankle foot Orthosis with neurodevelopmental treatment

Interventions

Dynamic flex cast with neurodevelopmental treatmentOTHER

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.

Dynamic flex cast with neurodevelopmental Group
Rigid Ankle foot Orthosis with neurodevelopmental treatmentOTHER

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

Rigid Ankle foot Orthosis with neurodevelopmental Group

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chal foundation, Bacha Khan Medical Complex

Swābi, KPK, 23430, Pakistan

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abrish Abbasi, MS-NMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 2, 2023

Study Start

February 25, 2023

Primary Completion

July 15, 2023

Study Completion

July 15, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)