NCT06502652

Brief Summary

Down Syndrome is a genetic condition caused by having an extra copy of chromosome 21 and 47 chromosomes instead of 46. A complete or partial extra copy of chromosome 21 is responsible for the anomaly and related structural and functional abnormalities of the body systems. Depending on the degree of abnormality, Down Syndrome has different impacts on different people as a result, differences exist in personality, abilities, talents, and physical and mental development. According to this syndrome the patients shared characteristics with one another that suggested they were siblings, including a broad, flat face, a small nose, a thick tongue, narrow palpebral fissures, obliquely positioned eyes, roundish and laterally extended cheeks, a long tongue, and varying degrees of intellectual impairment. Prior to the study, all participants will be informed of the purpose and method of conducting the research. Each of them will sign an informed consent release to participate in the project and to process personal data for scientific purposes. This study aimed to determine the effects of hippo therapy versus balance training on balance and functional mobility in children with Down's Syndrome. Randomized clinical trials will be done. The study will be conducted in special school of education, Sargodha and Najeeb ullah rehabilitation centre, Sargodha in 10 months duration after approval of synopsis. Evaluation will be done by using pediatric balance scale, times up to go test, Functional independence measure for children, Tug test for functional mobility. Non-probability convenient sampling will be used and the subjects will be allocated to two groups by random allocation through lottery method; group A will be receiving hippo therapy and group B will be receiving balance training. Both groups will receive 8 sessions for the period of 4 weeks. Measurements of all the outcome variables will be taken at baseline, 2nd and 4th week. Data will be analyzed using SPSS-21.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 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

Study Start

First participant enrolled

June 1, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

June 11, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

Balance training,Down syndrome,Hippotherapy

Outcome Measures

Primary Outcomes (3)

  • PEDIATRIC BALANCE SCALE

    It is modified berg scale the 14 items on the scale are: standing balance, sitting balance, transfers, stepping, reaching forward with outstretched arm, reaching the floor, turning, and placing foot on stool

    4 weeks

  • TIMES UP TO GO TEST

    The TUG was performed from a chair 40 cm high. Participants were instructed to stand and walk 3 m to a designated area at a regular pace, then turn and return to the starting position, with the time to finish being recorded. Each participant received two trials, with the best time noted.

    4 weeks

  • FUNCTIONAL INDEPENDENCE MEASURE

    The maximum score on each of the 18 elements in the FIM is 7, the minimum score is 1, and the maximum possible score is 126 points. The 18 items in the FIM can be split down into two categories: five items for assessing cognitive ADL (which includes two items for communication and three items for social cognition) and thirteen items for testing motor ADL

    4 weeks

Study Arms (2)

hippotherapy

EXPERIMENTAL

Group A includes Hippo Therapy. A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic. Child with down syndrome will be seated on the stimulator for 10-15 minutes every session. The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally

Other: hippotherapy

balance training

ACTIVE COMPARATOR

The therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill. Treadmill training completed under three conditions in 1-min training cycles. For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s. Each child repeated this procedure 20 Times and cool down for 5 minutes

Other: balance training

Interventions

A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic. Child with down syndrome will be seated on the stimulator for 10-15 minutes every session. The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally

hippotherapy

The therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill. Treadmill training completed under three conditions in 1-min training cycles. For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s. Each child repeated this procedure 20 Times and cool down for 5 minutes

balance training

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age group of 6-14 years
  • Both genders

You may not qualify if:

  • Children with fixed deformity in LE
  • Child with visual and hearing problems
  • History of epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Baburamani AA, Patkee PA, Arichi T, Rutherford MA. New approaches to studying early brain development in Down syndrome. Dev Med Child Neurol. 2019 Aug;61(8):867-879. doi: 10.1111/dmcn.14260. Epub 2019 May 17.

    PMID: 31102269BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • faiza khalid, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participant will get seperate treatment protocols and possible effort will be put to mask the both group about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: it will be randomized controlled trial which is non probability sampling will be used. two groups of 6-14 years age will be performed in which participants will be randomly divided.group a will recieve hippotherapy and group b will recieve balance training.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

July 16, 2024

Study Start

June 1, 2024

Primary Completion

July 15, 2024

Study Completion

July 30, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations