NCT05460936

Brief Summary

Cerebral Palsy is a developmental disorder caused by damage to the brain before, during or after birth. Spastic Cerebral Palsy is one of the most common types of cerebral Palsy. It affects about 80% of cerebral palsy. Spastic CP is characterized by increased muscle tone, jerky movements, joint stiffness, and muscle tightness. Spastic Cerebral primarily affects strength, coordination, and balance resulting in gait difficulties and affecting gross motor functioning. These abnormalities affect the very basic activities of daily life (ADLs). Even if the child is able to walk the motor skills are usually disturbed which are very important to improve and maintain gross motor functioning. Physical therapy plays a vital role in overcoming these issues.

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
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

July 14, 2022

Last Update Submit

November 8, 2022

Conditions

Keywords

cerebral palsy. gait training, motor learning, functional training, balance, hemiplegic gait.

Outcome Measures

Primary Outcomes (3)

  • 1-minute walk test

    1-minute walk test will be used to measure the functional ability of the child. This is a cost-effective and user-friendly tool which makes it a very suitable tool to be used in various clinical settings. This tool is selected because of the low attention span and ability of children to perform other tests. This test can be conducted in a short duration of time giving the required results

    8th week

  • Single leg stance

    a. The single-leg stance test is used to check the balance control along with the static posture control on the affected side. This tool is considered valuable and effective in monitoring the musculoskeletal; status and neurological status of the individual

    8th week

  • Gross Motor Function Measurement

    The Gross Motor Function Measure31 is a criterion-referenced assessment designed to be used with children with cerebral palsy. It evaluates the child's ability to complete motor functions, such as rolling, crawling, sitting, standing, walking, running, stair use, and jumping.

    8th Week

Study Arms (2)

conventional physical therapy

ACTIVE COMPARATOR

Resistive Exercises Stretching exercise of quadriceps , hamstring adductors and abductors.

Other: conventional physical therapy

Lower Extremity Functional Training

EXPERIMENTAL

motor learning, skill progression, and resistance training to target the balance, strength, and coordination impairments of the lower extremities. Motor learning will be based on strength and balance training using tandem walks, balance boards, and one-leg standing. Skill progression will be used to challenge the LIFT and the strength training will be achieved by performing sit-to-stand, sit-ups, stair climbs, and vertical jumps

Other: Lower Extremity Functional Training

Interventions

motor learning, skill progression, and resistance training to target the balance, strength, and coordination impairments of the lower extremities. Motor learning will be based on strength and balance training using tandem walks, balance boards, and one-leg standing. Skill progression will be used to challenge the LIFT and the strength training will be achieved by performing sit-to-stand, sit-ups, stair climbs, and vertical jumps

Lower Extremity Functional Training

Resistive Exercises Stretching exercise of quadriceps , hamstring adductors and abductors.

conventional physical therapy

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients who are not able to stand
  • Age between 7 to 16 years
  • Patients living near the designated center

You may not qualify if:

  • Patients with comorbidities
  • Patients with cognitive impairment
  • Patients who are not able to follow commands
  • Patients with a history of falls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

International Therapy Services Center

Lahore, Punjab Province, 40050, Pakistan

RECRUITING

Rising Sun Institute

Lahore, Punjab Province, 40050, Pakistan

RECRUITING

Related Publications (3)

  • Baldon Rde M, Serrao FV, Scattone Silva R, Piva SR. Effects of functional stabilization training on pain, function, and lower extremity biomechanics in women with patellofemoral pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):240-251, A1-A8. doi: 10.2519/jospt.2014.4940. Epub 2014 Feb 25.

    PMID: 24568258BACKGROUND
  • Vereijken A, Aerts I, Jetten J, Tassignon B, Verschueren J, Meeusen R, van Trijffel E. Association between Functional Performance and Return to Performance in High-Impact Sports after Lower Extremity Injury: A Systematic Review. J Sports Sci Med. 2020 Aug 13;19(3):564-576. eCollection 2020 Sep.

    PMID: 32874110BACKGROUND
  • Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Sports Health. 2019 Mar/Apr;11(2):149-156. doi: 10.1177/1941738118821929. Epub 2019 Jan 14.

    PMID: 30638439BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wajiha Shahid, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

July 14, 2022

First Posted

July 15, 2022

Study Start

May 18, 2022

Primary Completion

November 15, 2022

Study Completion

November 25, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations