Halliwick and Aquatic Exercises in Spastic Cerebral Palsy

April 11, 2022 updated by: Riphah International University

Comparison of Halliwick Exercises and Aquatic Excercices on Gross Motor Function, Trunk Stability and Hand Function in Spastic CP

The aim of this research is to find and compare the effects of halliwick exercises and aquatic exercises on gross motor function, trunk stability and hand function in spastic cerebral palsy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Randomized controlled trials done at Dream Child institute and Children hospital complex Multan. The sample size was 32. The subjects were divided in two groups, 16 subjects in halliwick exercise group and 20 in aquatic exercise group. Study duration was of 6 months. Sampling technique applied was convenient non probability sampling technique. Only 13-16 years diagnosed spastic cerebral pals individuals were included. Tools used in the study are Gross motor function measure (GMFM-66), Trunk impairment scale (TIS) and Nine-hole peg test (NHPT). Data was being analyzed through SPSS 22.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Binash Afzal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both genders Male & female
  • Age 13-16 years
  • Able to use assistive devices
  • Diagnosed CP children
  • Able to follow verbal commands

Exclusion Criteria:

  • Unstable seizures

    • had a surgery for the last 12 months or receive medication for spasticity
    • Associated cognitive issue
    • Incontinence
    • Persistent infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Aquatic exercises
this group receives sessions for consecutive 8 weeks and 3 days per week. warm up for 10 min, that will include walking in shallow water and stretchings of upper and lower extremities. After that APE for 30 min followed cool down period for 5 min. exercise frequency is 3 sets of each exercise with 15 repetitions.
Other: aquatic exercises
aquatic polymetric exercises for 30 min including hip abduction/adduction, knee flexion/extension, hip flexion/extension, holding pool from sides, bending forward and picking up objects, shoulder flexion/extension kangroo jumpes, jumping to sides.
Other: halliwick exercise programme
Halliwick exercise programme for 30 min include sagittal rotations, transversal rotations, longitudnal rotations and combined rotations.
EXPERIMENTAL: Halliwick exercise programme
this group receives sessions for consecutive 8 weeks and 3 days per week. warm up for 10 min that specifically includes mental adjustments along with walking in shallow side of pool and static stretchings. After that Halliwick exercise programme for 30 min that followed by cool down period for 5 min. exercise frequency is 3 sets of each exercise with 15 repetitions.
Other: aquatic exercises
aquatic polymetric exercises for 30 min including hip abduction/adduction, knee flexion/extension, hip flexion/extension, holding pool from sides, bending forward and picking up objects, shoulder flexion/extension kangroo jumpes, jumping to sides.
Other: halliwick exercise programme
Halliwick exercise programme for 30 min include sagittal rotations, transversal rotations, longitudnal rotations and combined rotations.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
GMFM-88
Time Frame: first reading at 0 week
It is an observational clinical measure designed to evaluate gross motor function in children with cerebral palsy.
first reading at 0 week
GMFM-88
Time Frame: final reading at 8 week
It is an observational clinical measure designed to evaluate gross motor function in children with cerebral palsy.
final reading at 8 week
Trunk Impairment Scale
Time Frame: First reading at 0 week
this scale measures static sitting and dynamic balance as well as trunk co-ordination. this aims to score the quality of trunk movement and to be as a guide for treatment.
First reading at 0 week
Trunk Impairment Scale
Time Frame: Final reading at 8 week
this scale measures static sitting and dynamic balance as well as trunk co-ordination. this aims to score the quality of trunk movement and to be as a guide for treatment.
Final reading at 8 week
Nine Hole Peg Test
Time Frame: first reading at 0 week
it is a standerized test for measuring hand function and finger dexterity. scoring is done on the basis of average time for consecutive 4 trial with dominant hand and then by non-dominant hand.
first reading at 0 week
Nine Hole Peg Test
Time Frame: final reading at 8 week
it is a standerized test for measuring hand function and finger dexterity. scoring is done on the basis of average time for consecutive 4 trial with dominant hand and then by non-dominant hand.
final reading at 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RiphahIU Nimra Arif

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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