Down SyndromeNCT06131099
Effects of Dohsa Hou Exercises on Functional Mobility
A study testing Dohsa hou exercises and Standard treatment protocal in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Trisomy 21 is a condition where there's an extra chromosome 21, which leads to a set of clinical signs called Down syndrome. Down syndrome is one of the most complicated genetic conditions that can occur post-term and is the most commonly survivable form of aneuploidy of the autosomal chromosomes. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Dohsa hou exercises and Standard treatment protocal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Down syndrome
- Age group of 6 to 12 years old
- Male and female (both genders)
- Body mass index (BMI) within normal range <95%
- Absence of any psychiatric and physical illness at the time of participation.
Who cannot join
- Uncontrolled seizures
- Any kind of autoimmune diseases
- Registered visually impaired or hearing issues
- Severe atlanto axial instability
- Congenital heart defects (CHD)
- Unable or unwilling to understand the commands
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Dohsa Hou Exercises on Functional Mobility in Children With Down Syndrome
Trisomy 21 is a condition where there's an extra chromosome 21, which leads to a set of clinical signs called Down syndrome. Down syndrome is one of the most complicated genetic conditions that can occur post-term and is the most commonly survivable form of aneuploidy of the autosomal chromosomes.
Dohsa hou is a type of psychomotor therapy that helps improve psychological problems by using bodily movements, sensation and relaxation experience. It was first developed under the name psycho-rehabilitation to help children with cerebral palsy improve their movements and posture. By using Dohsa hou movement's issues were effectively addressed in children with cerebral palsy, despite their physical limitations being caused by physiological disorders. There are two kind of treatments of Dohsa hou exercises that are relaxation therapy to decrease the stress level in body and other one is to align the body to correct the posture and movements of the body.
Read the detailed description
This study will be a randomized control trial, used to compare the effects of Dohsa hou exercises on functional mobility in children with Down syndrome. Subjects with Down syndrome meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling techniques. Assessment will be done by using Test of trunk impairment scale and Time Up and Go Test. Subjects in one group will be treated with Dohsa hou therapy and in other group standard treatment protocol.
- Conditions
- Down Syndrome
- Being tested
- Dohsa hou exercises, Standard treatment protocal
- Keywords
- Dohsa hou exercise, Down syndrome, Psychomotor therapy
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dohsa hou exercisesOther
Dohsa hou is a type of psychomotor therapy that helps improve psychological problems by using bodily movements, sensation and relaxation experience.
Standard treatment protocalOther
Standard treatment including soft tissue massage therapy, task specific training interventions, bicycle training and aerobic exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | In this group patient will be treated with standard treatment protocol. This group will receive therapy session for 1 hour, three sessions in a week and for 6 weeks, total sessions will be 18. Group A will receive soft tissue massage therapy for 5 mins and the task specific training interventions include bicycle training for 10 mins. After that aerobic exercises includes and finally some of progressive resistive exercises will involve in it. Receives: Other: Standard treatment protocal |
| Group B | Active comparator | In this group patient will be treated with Dohsa hou exercises. This group will receive therapy session for 1 hour, three sessions in a week and for 6 weeks, total sessions will be 18. Group B will receive Dohsa hou exercises, session will be included three activity parts: (a) 10 minutes of instruction and preparation, (b) 45 minutes of skill instruction and practice, and (c) 5 minutes in a closing activity. Receives: Other: Dohsa hou exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk impairment scale
The trunk impairment scale will be used for this study to identify the balance and coordination in sitting and standing state. The assessment tool uses a 2 to 4 point ranking system for each item. The highest possible scores for the static and dynamic sitting balance and coordination scales are 7, 10 and 6 points. The TSI score can range from 0 to 23, with a score of 0 indicating minimal performance and a perfect score of 23.
Measured: 6 weeks
Time up and go
Time up and go test will be used to assess the balance and stability of a children with different abilities. It involves timing how long it takes for a child to stand up from a chair, walk a short distance, turn around, walk back, and sit down while turning 180 degree.
Interpretation: < 10 seconds = normal, < 20 seconds = good mobility, can go out alone, mobile without a gait aid. < 30 seconds = problems, cannot go outside alone, requires a gait aid. A score of more than or equal to fourteen seconds has been shown to indicate high risk of falls.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start15 Nov 2023
- Primary completion15 Feb 2024
- Study completion28 Feb 2024
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 SyndromeStudies of the same condition, open and under way.
- 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
- Its a randomized control trail, used to compare the effects of Dohsa hou exercises on functional mobility in children with Down syndrome. Subjects with Down syndrome meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Asif Javed, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131099
- Sponsor's protocol ID
- REC/RCR&AHS/23/0762
- Status last verified
- Jun 2024
- First submitted
- 9 Nov 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fujino H, Moritsugu A. Dohsa-hou for unexplained regression in Down syndrome in a 19-year-old man: A case report. Clin Case Rep. 2022 May 15;10(5):e05827. doi: 10.1002/ccr3.5827. eCollection 2022 May.
PubMed 35600012
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dohsa Hou Exercises on Functional Mobility in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06131099
- Acronym / sponsor ID
- REC/RCR&AHS/23/0762
- Conditions
- Down Syndrome
- Keywords
- Dohsa hou exercise, Down syndrome, Psychomotor therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 14 Nov 2023 (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.
Trisomy 21 is a condition where there's an extra chromosome 21, which leads to a set of clinical signs called Down syndrome. Down syndrome is one of the most complicated genetic conditions that can occur post-term and is the most commonly survivable form of aneuploidy of the autosomal chromosomes.
Dohsa hou is a type of psychomotor therapy that helps improve psychological problems by using bodily movements, sensation and relaxation experience. It was first developed under the name psycho-rehabilitation to help children with cerebral palsy improve their movements and posture. By using Dohsa hou movement's issues were effectively addressed in children with cerebral palsy, despite their physical limitations being caused by physiological disorders. There are two kind of treatments of Dohsa hou exercises that are relaxation therapy to decrease the stress level in body and other one is to align the body to correct the posture and movements of the body.
Detailed description
This study will be a randomized control trial, used to compare the effects of Dohsa hou exercises on functional mobility in children with Down syndrome. Subjects with Down syndrome meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling techniques. Assessment will be done by using Test of trunk impairment scale and Time Up and Go Test. Subjects in one group will be treated with Dohsa hou therapy and in other group standard treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Its a randomized control trail, used to compare the effects of Dohsa hou exercises on functional mobility in children with Down syndrome. Subjects with Down syndrome meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Standard treatment protocalIn this group patient will be treated with standard treatment protocol. This group will receive therapy session for 1 hour, three sessions in a week and for 6 weeks, total sessions will be 18. Group A will receive soft tissue massage therapy for 5 mins and the task specific training interventions include bicycle training for 10 mins. After that aerobic exercises includes and finally some of progressive resistive exercises will involve in it. |
| Group B | Active comparator | Other: Dohsa hou exercisesIn this group patient will be treated with Dohsa hou exercises. This group will receive therapy session for 1 hour, three sessions in a week and for 6 weeks, total sessions will be 18. Group B will receive Dohsa hou exercises, session will be included three activity parts: (a) 10 minutes of instruction and preparation, (b) 45 minutes of skill instruction and practice, and (c) 5 minutes in a closing activity. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Down syndrome
- Age group of 6 to 12 years old
- Male and female (both genders)
- Body mass index (BMI) within normal range <95%
- Absence of any psychiatric and physical illness at the time of participation.
Key exclusion criteria (6 listed)
- Uncontrolled seizures
- Any kind of autoimmune diseases
- Registered visually impaired or hearing issues
- Severe atlanto axial instability
- Congenital heart defects (CHD)
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 |
|---|---|---|
| Dohsa hou exercisesDohsa hou is a type of psychomotor therapy that helps improve psychological problems by using bodily movements, sensation and relaxation experience. | Other | Group B |
| Standard treatment protocalStandard treatment including soft tissue massage therapy, task specific training interventions, bicycle training and aerobic exercises. | Other | Group A |
Primary outcome
Trunk impairment scale
Time frame: 6 weeks
The trunk impairment scale will be used for this study to identify the balance and coordination in sitting and standing state. The assessment tool uses a 2 to 4 point ranking system for each item. The highest possible scores for the static and dynamic sitting balance and coordination scales are 7, 10 and 6 points. The TSI score can range from 0 to 23, with a score of 0 indicating minimal performance and a perfect score of 23.
Time up and go
Time frame: 6 weeks
Time up and go test will be used to assess the balance and stability of a children with different abilities. It involves timing how long it takes for a child to stand up from a chair, walk a short distance, turn around, walk back, and sit down while turning 180 degree. Interpretation: < 10 seconds = normal, < 20 seconds = good mobility, can go out alone, mobile without a gait aid. < 30 seconds = problems, cannot go outside alone, requires a gait aid. A score of more than or equal to fourteen seconds has been shown to indicate high risk of falls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 35600012Fujino H, Moritsugu A. Dohsa-hou for unexplained regression in Down syndrome in a 19-year-old man: A case report. Clin Case Rep. 2022 May 15;10(5):e05827. doi: 10.1002/ccr3.5827. eCollection 2022 May.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Muhammad Asif Javed, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dohsa hou exercises and Standard treatment protocal in people with Down Syndrome, run by Riphah International University at 1 site 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk impairment scale (time frame: 6 weeks). 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 NCT06131099, 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 13 Jun 2024.