NCT05719636

Brief Summary

In this research the effects of progressive resistance exercise training on endurance and functional mobility in children with spina bifida are assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

Study Start

First participant enrolled

May 13, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

January 31, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

resistance exerciseendurancefunctional mobility

Outcome Measures

Primary Outcomes (1)

  • Patient Specific Functional Scale for lower extremity functional status

    Patient Specific Functional Scale (PSFS) was developed by Stratford et al 1995 as a self-report outcome measure of function that could be used in patients with varying levels of independence. The aim of PSFS is to provide clinicians with a valid, reliable, responsive and efficient outcome measure that would be easy to use and applicable to a large number of clinical presentations. Gives the patient positive re-enforcement that the intervention is effective. Can be used on a wide variety of musculoskeletal and neurological conditions

    6th week

Secondary Outcomes (2)

  • 6 minute walk test

    6th week

  • sit to stand test

    6th Week

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR
Other: Conventional treatment

Progressive resistance exercise

EXPERIMENTAL
Other: Progressive resistance exercise

Interventions

Conventional protocol that involves simple active and passive range of motion exercises of lower limb with positioning for assistive devices was provided

Conventional treatment

The protocol that was applied on the members of (experimental group) are progressive resistance exercises. These passive resistance exercises included Flexion, Extension, Abduction, Adduction of hip; Flexion, Extension of knee; with minimum time in start and minimum quantity of loads, with Thera bands and sandbags,.

Progressive resistance exercise

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 16 year.
  • Male and female both are included.
  • Lower extremity weakness (less than 2).
  • Knee and hip flexion contractures

You may not qualify if:

  • Bowel and bladder dysfunction.
  • Children having absent tone.
  • Children having bone fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Fareeha Kausar, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

May 13, 2022

Primary Completion

April 15, 2023

Study Completion

April 20, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations