Hippotherapy Versus Balance Therapy on Funvtional Mobility in Down Syndrome

NCT ID: NCT06502652

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-07-30

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.

Detailed Description

GROUP A:

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

GROUP B Group B includes balance training. 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

Conditions

Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

hippotherapy

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

Group Type: EXPERIMENTAL

hippotherapy

Intervention Type: OTHER

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

balance training

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

Group Type: ACTIVE_COMPARATOR

balance training

Intervention Type: OTHER

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

Interventions

hippotherapy

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

Intervention Type: OTHER

balance training

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age group of 6-14 years
• Both genders

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

faiza khalid, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 31102269 (View on PubMed)

Other Identifiers

REC/RCR&AHS/23/0797

Identifier Type: -

Identifier Source: org_study_id