NCT06407765

Brief Summary

Cerebral palsy is a non progressive neurodevelopmental disorder that usually effects the muscles of the patients effecting its tone, strength and eventually ability to move. Dual tasking training incorporates more than one task at a time, it can b either physical task with movement or mental tasks. Backward walking is used to challenge the proprioception. The study is a randomized controlled trial to assess the effects of Dual task training with and without Backward walking on balance, activity and participations on children with cerebral palsy. Study will be conducted in PSRD and Rehab care. Sample will be recruited randomly and then divided into two groups control and experimental group. Control group will receive dual task training and experimental group will receive both dual task training and backward walking. This treatment would continue for 4 weeks. Patient will be assessed both at the start and end of 4 weeks. The outcome tools for assessment of balance, activity and participation will be following: Pediatric Berg Balance Scale, Time up and Go test and Participation of daily life PODCI Questionnaire. Ethical consideration will be followed and informed consent will be taken from legal guardians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

May 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

May 6, 2024

Last Update Submit

July 28, 2024

Conditions

Keywords

Cerebral PalsyDual task trainingBackward WalkingActivityBalance

Outcome Measures

Primary Outcomes (3)

  • Pediatric Berg Balance Scale

    A version of Berg's Balance Scale, the Pediatrics Balance Scale (PBS) was created as a balancing assessment for school-age children with mild to moderate motor deficits. There is a 0.998 intra-class correlation value (ICC).

    4 weeks

  • Time up and go test

    In clinical practice, the "timed up and go" (TUG) test is a brief assessment tool used to evaluate adults' functional mobility. The TUG test has a high level of dependability in children as well, with an ICC of 0.99 both within a session and between tests.

    4 weeks

  • Participation of Daily Life PODCI Questionnaire

    The PODCI is a parent-reported outcome measure that evaluates children's expectations of healthcare interventions as well as their mobility, physical function, comfort, and happiness. When assessing quality of life issues and walking function in children with cerebral palsy, the PODCI shows good validity and reliability.

    4 weeks

Study Arms (2)

Dual Task Training

ACTIVE COMPARATOR

This group will receive Dual task training

Other: Dual task training

Dual task training with Backward walking

EXPERIMENTAL

This group will receive both Dual task training with Backward walking

Other: Dual task training with backward walking

Interventions

Dual task training incorporates both cognitive and motor tasks. Tasks like walking and asking the patient to point towards objects, collect start from the objects hanging above the patient and asking the patient to name the objects shown to him/her. This treatment will be given for 4 weeks, 4 times a week for 40 minutes. Each task is done for 7 minutes with a 3 minutes break in between.

Dual Task Training

This group will get both dual task training and backward walking. For dual task training same protocol as active comparator is followed. For backward walking; the patient is firstly asked to walk backward with complete physiotherapist assistance. Secondly, the patient is asked to walk for 15 m through the treatment room's hallway while holding a safety bar with the hand on the unaffected side. Third, without using a safety bar, the participants were urged to walk freely. Lastly, the participants tried to walk backwards at a reasonable pace while progressively increasing their distance travelled and speed. This treatment will be given for 4 weeks, 4 times a week for 40 minutes. Each task is done for 7 minutes with a 3 minutes break in between.

Dual task training with Backward walking

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with cerebral palsy who have already received a diagnosis
  • Children with GMFCS Level I-II
  • Children between the ages of 6 and 12

You may not qualify if:

  • Being unable to complete the cognitive task, which involves counting back one after each number between 0 and 100
  • Posing a behavioral issue that makes it challenging to engage in the study
  • Being unable to walk independently
  • Children with concomitant cardiac conditions
  • Any musculoskeletal surgery performed during the previous six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 540000, Pakistan

Location

Related Publications (1)

  • Fisher-Pipher S Pt Dpt, Kenyon LK Pt Dpt PhD Pcs, Westman M Pt Dpt. Improving balance, mobility, and dual-task performance in an adolescent with cerebral palsy: A case report. Physiother Theory Pract. 2017 Jul;33(7):586-595. doi: 10.1080/09593985.2017.1323359. Epub 2017 May 16.

    PMID: 28509631BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Aqsa Butt, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Both group will receive separate treatment and effort will be put to mask the both groups about treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It will be a Randomized control trail. Convenient random sampling is used to collect the sample. The population under study is Cerebral palsy children. The study sample group are between the age of 6 to 12. The group is randomly divided into two groups; Control and experimental group. The control group will receive Dual task training. The experimental group will receive both dual task training and backward walking. The patients will be assesed at the start and then after 4 weeks of treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

May 16, 2024

Primary Completion

July 1, 2024

Study Completion

July 23, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations