Down Syndrome (DS)STOMPNCT06748248
Suspension Therapy Effects on Mobility and Balance in Down Syndrome
A study testing suspension Therapy and Routine Treatment in people with Down Syndrome (DS), run by Riphah International University at 2 sites in Pakistan.
Trial summary
Down syndrome (DS) is one of the most common congenital disorders. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Down Syndrome (DS)
- What is being tested?
- suspension Therapy and Routine Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesPakistan
- Study dates
- 24 Sep 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Visual and Hearing impairment
- Orthopedic limitation to exercise such as hip, knee, foot or spinal deformities
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54000
Imran Amjad, PhD, 9233224390125, Imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS, 03224209422, a.javed@riphah.edu.pk
- Recruiting
Riphah International Universiy
Lahore, Punjab Province
Imran Amjad, PhD, +9233224390125, imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS, 03224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Suspension Therapy on Mobility and Balance in Children With Down Syndrome
Down syndrome (DS) is one of the most common congenital disorders. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. These factors are responsible for the developmental challenges faced by children with Down syndrome. These individuals also present with balance dysfunctions. Neuromuscular and musculoskeletal impairments due to the chromosomal abnormality lead to developmental delay. These children also exhibit poor balance with greater instability and inefficient compensatory mechanisms including altered center of pressure displacement and trunk stiffening that predisposes them to falls. The aim of this study is to determine the Effects of Suspension Therapy (ST) on mobility and balance of children with Down syndrome. Suspension Therapy using Universal exercise Unit (UEU) is a three dimensional (3D) cage, consists of system of pulleys, suspensions, belts for supporting and elastic cords. Suspension Therapy is based on the concept of unloading the body against gravity and to perform movement of weak part of body.
Read the detailed description
The current study will be Randomized Controlled Trial. Inclusion criteria for the study will be children with Down syndrome (DS) of mild to moderate mental retardation aged between 3 and 6 years. Patients with any cardiac issue and orthopedic limitation to exercise such as hip, knee, foot or spinal deformities will be excluded from the study. A sample of 26 children with DS will be selected from both genders. Tools used for data collection will be Pediatric Balance scale (PBS), Four square step test (FSST), Timed up and Go test (TUG) and 1Minute Walk Test (1MWT). Participants will be measured before and after treatment to assess changes. Interventions are carried out 5 days in a week for one hour daily. In this study descriptive statistical tools will used to analyze the data. Data will be analyzed through SPSS version 23.00.
- Conditions
- Down Syndrome (DS)
- Being tested
- suspension Therapy, Routine Treatment
- Keywords
- Down syndrome, Suspension Therapy, Universal Exercise Unit, Pediatric Balance Scale, four Square Step Test, 1min Walk Test, Timed up and go test
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suspension TherapyOther
Also called universal exercise unit
suspension therapy for individuals with Down syndrome is an approach that focuses on improving mobility and balance through different activities that will be conducted through universal exercise unit. This method involves organizing individuals with Down syndrome into two groups. Group A will perform Suspension Therapy in addition to routine physical therapy. These routine exercises will consist of stretching exercises (arm raises, chest stretch, leg swings, hamstring stretch, cat-cow poses, starfish stretch), strength and endurance training (like stepping, carrying light weights) and balance training (playing hopscotch and kicking a ball). The exercise program will gradually increase in intensity in accordance with each participant's functional improvement. Suspension Therapy will consist of passive and active postural auto-correction exercises done repeatedly and based on kinesthetic and sensorimotor principles. Repeated corrective movements will be performed.
Routine TreatmentOther
Also called routine physical Therapy
Group B will perform routine physical therapy (RPT) alone. These routine exercises will consist of stretching exercises (particularly upper and lower body stretches and full body stretches). Stretches will be gentle and avoid bouncing. Hold for each stretch will be 15-30 seconds. Balance and coordination exercises (Walking on balance beams, obstacle courses) will be performed as RPT. The exercise program will gradually increase in intensity in accordance with each participant's functional improvement. These exercises will be carried out 5 days in a week for one hour daily.
Data will be assessed by assessor at baseline and at the end of 5th session of treatment (Pre and post).
| Study group | Role | What they receive |
|---|---|---|
| suspension therapy | Experimental | Universal Exercise Unit also named Spider cage and Monkey cage. This device will used in this study. This system helps the children to weight shift, more independent movement and assisted movement such as sit to stand, squats and jumping. Receives: Other: suspension Therapy |
| Routine Treatment | Other | These routine exercises will consist of stretching exercises (particularly upper and lower body stretches and full body stretches). Stretches will be gentle and avoid bouncing. Hold for each stretch will be 15-30 seconds. Balance and coordination exercises (Walking on balance beams, obstacle courses) will be performed as RPT. The exercise program will gradually increase in intensity in accordance with each participant's functional improvement. These exercises will be carried out 5 days in a week for one hour daily. Receives: Other: Routine Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 Minute Walk Test
The distance covered during the 1 minute walk test was compared with the children gross motor function as assessed by the Gross Motor Function Measure. We concluded that the 1 Minute Walk Test is a valid measure for assessing functional ability in children with bilateral spastic cerebral palsy. Its cost effectiveness and user friendliness make it a potentially useful tool in the clinical setting. The test retest reliability of a 1 minute walk test at a child maximum walking speed was assessed in children with bilateral spastic cerebral palsy. A 1 minute walk test is a reliable method of assessing function in children with Cerebral palsy but care must be taken when interpreting changes in individual patient data.
Measured: 1 minute
Four Square Step Test
Four Square Step Test is a tool for measuring balance in children with Down syndrome by stepping over four squares. The Four Square Step Test is a balance and mobility assessment that evaluates a persons ability to step quickly and accurately in multiple directions. Participants step in and out of four squares arranged in a cross pattern starting from one of the outer squares and moving through a sequence. The test is timed and results help identify balance impairments and fall risks. A completion time of under 15 seconds is generally considered normal.
Measured: 15 seconds
Secondary outcomes (2)
Pediatric balance scale
The Pediatric Balance Scale a modification of the Berg Balance Scale will be used as a balance measure for children. The pediatric balance scale measure can be performed without specialized equipment and is quickly and easily administered. The Pediatric balance scale has been used to measure the balance functions for school age children with mild to moderate motor impairment and children with Cerebral palsy. The tasks range from timed sitting balance to standing on one leg. This study confirmed good validity of the Pediatric balance scale and its capability to predict motor function and Activity of daily living at follow up. The Pediatric balance scale static dynamic and total were moderately responsive to change.
Measured: 15 to 20 minutes
Timed Up and Go Test
The Timed Up and Go Test is a quick assessment used to evaluate mobility and balance primarily in older adults. It measures the time it takes for a participant to stand up from a chair walk 3 meters or 10 feet turn around walk back and sit down. The total time is recorded with results helping to identify fall risk and assess functional mobility. A completion time under 10 seconds is typically considered normal while over 12 seconds may indicate an increased risk of falls.
Measured: The Timed Up and Go Test typically takes about 5 to 10 minutes to complete. This includes time for instructions the actual test which usually lasts 10 to 30 seconds depending on the individual and scoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start24 Sep 2024
- Primary completion10 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down Syndrome (DS)Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be randomized control trial in which non probability convenient sampling will be used. two groups of 3-6 age will be formed in which participants will be randomly divided. Group A will be receive Suspension Therapy. Group B will be receive routine therapy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Rukhsar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748248
- Sponsor's protocol ID
- REC/RCR/AHS/24/Sidra Rukhsar
- Acronym
- STOMP
- Status last verified
- Dec 2024
- First submitted
- 3 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendez-Martinez M, Rodriguez-Grande EI. Effects of therapeutic exercise on the motor function of adults with Down syndrome: a systematic review and meta-analysis. Sci Rep. 2023 Dec 11;13(1):21962. doi: 10.1038/s41598-023-48179-1.
PubMed 38081839
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Suspension Therapy on Mobility and Balance in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06748248
- Acronym / sponsor ID
- STOMP / REC/RCR/AHS/24/Sidra Rukhsar
- Conditions
- Down Syndrome (DS)
- Keywords
- Down syndrome, Suspension Therapy, Universal Exercise Unit, Pediatric Balance Scale, four Square Step Test, 1min Walk Test, Timed up and go test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Down syndrome (DS) is one of the most common congenital disorders. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. These factors are responsible for the developmental challenges faced by children with Down syndrome. These individuals also present with balance dysfunctions. Neuromuscular and musculoskeletal impairments due to the chromosomal abnormality lead to developmental delay. These children also exhibit poor balance with greater instability and inefficient compensatory mechanisms including altered center of pressure displacement and trunk stiffening that predisposes them to falls. The aim of this study is to determine the Effects of Suspension Therapy (ST) on mobility and balance of children with Down syndrome. Suspension Therapy using Universal exercise Unit (UEU) is a three dimensional (3D) cage, consists of system of pulleys, suspensions, belts for supporting and elastic cords. Suspension Therapy is based on the concept of unloading the body against gravity and to perform movement of weak part of body.
Detailed description
The current study will be Randomized Controlled Trial. Inclusion criteria for the study will be children with Down syndrome (DS) of mild to moderate mental retardation aged between 3 and 6 years. Patients with any cardiac issue and orthopedic limitation to exercise such as hip, knee, foot or spinal deformities will be excluded from the study. A sample of 26 children with DS will be selected from both genders. Tools used for data collection will be Pediatric Balance scale (PBS), Four square step test (FSST), Timed up and Go test (TUG) and 1Minute Walk Test (1MWT). Participants will be measured before and after treatment to assess changes. Interventions are carried out 5 days in a week for one hour daily. In this study descriptive statistical tools will used to analyze the data. Data will be analyzed through SPSS version 23.00.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be randomized control trial in which non probability convenient sampling will be used. two groups of 3-6 age will be formed in which participants will be randomly divided. Group A will be receive Suspension Therapy. Group B will be receive routine therapy.
| Arm | Type | Receives |
|---|---|---|
| suspension therapy | Experimental | Other: suspension TherapyUniversal Exercise Unit also named Spider cage and Monkey cage. This device will used in this study. This system helps the children to weight shift, more independent movement and assisted movement such as sit to stand, squats and jumping. |
| Routine Treatment | Other | Other: Routine TreatmentThese routine exercises will consist of stretching exercises (particularly upper and lower body stretches and full body stretches). Stretches will be gentle and avoid bouncing. Hold for each stretch will be 15-30 seconds. Balance and coordination exercises (Walking on balance beams, obstacle courses) will be performed as RPT. The exercise program will gradually increase in intensity in accordance with each participant's functional improvement. These exercises will be carried out 5 days in a week for one hour daily. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Visual and Hearing impairment
- Orthopedic limitation to exercise such as hip, knee, foot or spinal deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suspension TherapyAlso: universal exercise unitsuspension therapy for individuals with Down syndrome is an approach that focuses on improving mobility and balance through different activities that will be conducted through universal exercise unit. This method involves organizing individuals with Down syndrome into two groups. Group A will perform Suspension Therapy in addition to routine physical therapy. These routine exercises will consist of stretching exercises (arm raises, chest stretch, leg swings, hamstring stretch, cat-cow poses, starfish stretch), strength and endurance training (like stepping, carrying light weights) and balance training (playing hopscotch and kicking a ball). The exercise program will gradually increase in intensity in accordance with each participant's functional improvement. Suspension Therapy will consist of passive and active postural auto-correction exercises done repeatedly and based on kinesthetic and sensorimotor principles. Repeated corrective movements will be performed. | Other | suspension therapy |
| Routine TreatmentAlso: routine physical TherapyGroup B will perform routine physical therapy (RPT) alone. These routine exercises will consist of stretching exercises (particularly upper and lower body stretches and full body stretches). Stretches will be gentle and avoid bouncing. Hold for each stretch will be 15-30 seconds. Balance and coordination exercises (Walking on balance beams, obstacle courses) will be performed as RPT. The exercise program will gradually increase in intensity in accordance with each participant's functional improvement. These exercises will be carried out 5 days in a week for one hour daily. Data will be assessed by assessor at baseline and at the end of 5th session of treatment (Pre and post). | Other | Routine Treatment |
Primary outcome
1 Minute Walk Test
Time frame: 1 minute
The distance covered during the 1 minute walk test was compared with the children gross motor function as assessed by the Gross Motor Function Measure. We concluded that the 1 Minute Walk Test is a valid measure for assessing functional ability in children with bilateral spastic cerebral palsy. Its cost effectiveness and user friendliness make it a potentially useful tool in the clinical setting. The test retest reliability of a 1 minute walk test at a child maximum walking speed was assessed in children with bilateral spastic cerebral palsy. A 1 minute walk test is a reliable method of assessing function in children with Cerebral palsy but care must be taken when interpreting changes in individual patient data.
Four Square Step Test
Time frame: 15 seconds
Four Square Step Test is a tool for measuring balance in children with Down syndrome by stepping over four squares. The Four Square Step Test is a balance and mobility assessment that evaluates a persons ability to step quickly and accurately in multiple directions. Participants step in and out of four squares arranged in a cross pattern starting from one of the outer squares and moving through a sequence. The test is timed and results help identify balance impairments and fall risks. A completion time of under 15 seconds is generally considered normal.
2 secondary outcomes
Pediatric balance scale
Time frame: 15 to 20 minutes
Timed Up and Go Test
Time frame: The Timed Up and Go Test typically takes about 5 to 10 minutes to complete. This includes time for instructions the actual test which usually lasts 10 to 30 seconds depending on the individual and scoring.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 38081839Mendez-Martinez M, Rodriguez-Grande EI. Effects of therapeutic exercise on the motor function of adults with Down syndrome: a systematic review and meta-analysis. Sci Rep. 2023 Dec 11;13(1):21962. doi: 10.1038/s41598-023-48179-1.
- Individual participant dataSharing planned: No
Related trials for Down Syndrome (DS)
RecruitingPhase 2
A Study to Evaluate Mivelsiran in Adult Participants With Early-Stage Down Syndrome-Associated Alzheimer's Disease (DS-AD)
Down Syndrome-Associated Alzheimer's Disease (DS-AD)
Recruiting
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)
Obstructive Sleep Apnea, Down Syndrome
RecruitingObservational study
A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia
B Acute Lymphoblastic Leukemia Associated With Down Syndrome, Down Syndrome
Not yet recruitingPhase 1
NAD Augmentation to Prevent or Reverse Alzheimer's Disease in People With Down Syndrome
Down Syndrome (DS)
Recruiting
Adapting RDAD for DS
Down Syndrome (DS), Alzheimer's Disease (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sidra Rukhsar, MS principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suspension Therapy and Routine Treatment in people with Down Syndrome (DS), run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad Dr, PhD (9233224390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 Minute Walk Test (time frame: 1 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06748248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.