Evaluation of the effect of multi-component neuromuscular training on balance, strength, and sports performance of futsal players with Down syndrome
Design
A randomized, single-blind, controlled phase II clinical trial with a parallel group design of 30 participants, randomized using the RAND function in Microsoft Excel.
Settings and conduct
Tests are administered before and after the intervention, with participants results recorded. An eight‑week multi‑component neuromuscular training program is conducted, three sessions weekly (24 total). Each session lasts 40–45 minutes: 10 warm‑up, 30 training, 5 cool‑down. Group sessions take place at Behzisti and Pas sports halls in Rasht.
Participants/Inclusion and exclusion criteria
Inclusion Criteria of Participants:
Gender: male;
Age range: 20–30 years;
Diagnosis of Down syndrome;
IQ between 50 and 70, or being trainable;
Minimum of 3 years of sports experience;
Regular training (at least three sessions per week);
No history of lower limb injury in the past six months that could cause functional or structural limitations; no history of lower limb surgery that could alter the natural alignment of the body;
No evident orthopedic, perceptual, or musculoskeletal disorders;
No use of specific medications that could affect balance.
Exclusion Criteria of Participants:
Failure to cooperate in performing the pre-test or post-test;
Incomplete participation in the training program for any reason;
Absence from more than three training sessions or two consecutive sessions;
Experiencing pain or injury during training; unwillingness to continue participation.
Intervention groups
Intervention group: Participants perform multi-component neuromuscular training.
Control group: Participants receive no intervention and only engage in their daily activities.
Main outcome variables
Balance, lower limb muscle strength and sports performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251126068122N1
Registration date:2025-12-13, 1404/09/22
Registration timing:prospective
Last update:2025-12-13, 1404/09/22
Update count:0
Registration date
2025-12-13, 1404/09/22
Registrant information
Name
Masoomeh Evazkhah
Name of organization / entity
University of Guilan
Country
Iran (Islamic Republic of)
Phone
+98 13 4253 2837
Email address
masoomehek2000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2026-03-01, 1404/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multi component neuromuscular exercises on balance and sport performance of futsal players with down syndrome
Public title
The Effect of Exercise Training on the Sports Performance of Futsal Players with Down Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gender: Male
Age range: 20 to 30 years
Diagnosis of Down syndrome
IQ between 50 and 70, or being trainable
Minimum of 3 years of sports experience
Regular training (at least three sessions per week)
No history of lower limb injury in the past six months that could cause functional or structural limitations, and no history of lower limb surgery that could alter the natural alignment of the body
No evident orthopedic, perceptual, or musculoskeletal disorders
No use of specific medications that could affect balance
Exclusion criteria:
Failure to cooperate in performing the pre-test or post-test
Incomplete participation in the training program for any reason
Absence from more than three training sessions or two consecutive sessions
Experiencing pain or injury during training, or unwillingness to continue participation
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned to one of the two study groups using a random number table, and they receive the corresponding intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will not be informed about their allocation to the study groups and will be kept blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee in biomedical research of guilan university
Street address
5th Kilometer of Persian Gulf Highway، Rasht، Guilan Provience، Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.GUILAN.REC.1404.002
Health conditions studied
1
Description of health condition studied
Individual with Down syndrome
ICD-10 code
Q90
ICD-10 code description
Down syndrome
Primary outcomes
1
Description
Balance
Timepoint
The balance tests were assessed at baseline and after the eight week intervention.
Method of measurement
Stork Test and Y Balance Test
2
Description
Lower limb muscle strength
Timepoint
The Lower limb muscle strength tests were assessed at baseline and after the eight week intervention.
Method of measurement
30-Second Chair Stand Test
3
Description
Sports perfomance
Timepoint
Sport performance tests were assessed at baseline and after the eight week intervention.
Method of measurement
The assessments were selected from the futsal sports skill test battery for individuals with intellectual disabilities.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Multi-component neuromuscular exercises for eight weeks, three days per week, lasting 40 to 45 minutes.
Category
Rehabilitation
2
Description
Control group: During the eight week period, the control group performed their regular futsal training three days per week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Behzisti Sports Club, Rasht and Pas Sports Club, Rasht
5th Kilometer of Persian Gulf Highway، Rasht، Guilan Provience، Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3332 8845
Email
bani@guilan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Guilan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Masoomeh Evazkhah
Position
Master’s student
Latest degree
Bachelor
Other areas of specialty/work
Adapted Physical Education and Sport for People with Disabilities
Street address
5th Kilometer of Persian Gulf Highway، Rasht، Guilan Provience، Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
009842532837
Email
masoomehek2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Masoomeh Evazkhah
Position
Master’s student
Latest degree
Bachelor
Other areas of specialty/work
Adapted Physical Education and Sport for People with Disabilities
Street address
5th Kilometer of Persian Gulf Highway، Rasht، Guilan Provience، Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 4253 2834
Email
masoomehek2000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Masoomeh Evazkhah
Position
Master’s student
Latest degree
Bachelor
Other areas of specialty/work
Adapted Physical Education and Sport for People with Disabilities
Street address
5th Kilometer of Persian Gulf Highway، Rasht، Guilan Provience، Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 4253 2837
Email
masoomehek2000@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data from the measured variables will be shareable once individuals have been de-identified.
When the data will become available and for how long
The access period will begin in 1405 (2026).
To whom data/document is available
Only for researchers employed at academic and scientific institutions.
Under which criteria data/document could be used
The scientific use of the data for improvement and comparison with other research is allowed.
From where data/document is obtainable
Correspondence with researchers for obtaining necessary information can be directed to: masoomehek2000@gmail.com
What processes are involved for a request to access data/document
Requesters are required to submit the justification for using the documents to the following email address. The researcher will review the request and provide a response at the earliest opportunity: masoomehek2000@gmail.com