NCT05770778

Brief Summary

The 40-68% of ambulating hemiplegic children walk with genu recurvatum and hemiplegic patients shows excessive anterior pelvic tilts (\>4 cm) during the stance phase. The objective of the study is to compare the effects of inclined backward treadmill walk vs kneel walk on genu recurvatum in hemiplegic cerebral palsy. 50 participants will be chosen according to inclusion exclusion criteria of the study which will be randomly allocated into two equal groups . One group will receive treadmill training programme with specifically designed physical therapy program according to child need for one hour for each child. And other group will receive kneel walking programme specifically designed physical therapy program according to child need for one hour for each child. The pre and post assessment of genurecurvatum will be assessed by Goniometer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

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
unknown

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

February 3, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 15, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 24, 2023

Last Update Submit

March 14, 2023

Conditions

Keywords

Hemiplegic Cerebral PalsyGenu-RecurvatumInclined Backward WalkKneel walk.Treadmill training

Outcome Measures

Primary Outcomes (1)

  • Range of Motion

    The limit or length ranges of each plane of the joint

    Change from baseline at 3rd Month

Study Arms (2)

Inclined Backward Intervention Group

ACTIVE COMPARATOR

Hemiplegic Cerebral Palsy Children

Other: Inclined Backwalk

Kneel Walk Intervention Group

ACTIVE COMPARATOR

Hemiplegic Cerebral Palsy Children

Other: Knee Walk

Interventions

They will receive inclined backward treadmill gait training exercise for thirty minutes with 2 interval break for 5min every 10 minutes for three times per week over three successive months with a specifically designed physical therapy program according to child need for one hour for each child, three times weekly, over three months.

Inclined Backward Intervention Group

They will receive kneel walk exercise programme for thirty minutes with 2 interval break for 5min every 10 minutes for three times per week over three successive months with a specifically designed physical therapy program according to child need for one hour for each child , three times weekly, over three months.

Kneel Walk Intervention Group

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • GMFM level (I \& II)
  • knee hyperextension ranged from 10 to 20 degrees

You may not qualify if:

  • Children with comorbidities (other knee deformities, surgical intervention or fractures) will not included in this study.
  • Children who recently have botulinum toxin injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex, Lahore

Lahore, Punjab Province, 55201, Pakistan

RECRUITING

Study Officials

  • Momina Mehmood

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 15, 2023

Study Start

February 3, 2023

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

March 15, 2023

Record last verified: 2023-02

Locations