Down SyndromeNCT06576206
Effects of Bin Therapy on Finger Gnosia And Fine Motor Skill
A study testing Bin therapy and finger gnosia and conventional therapy in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Down syndrome is a hereditary disorder resulting from the occurrence of an additional copy of chromosome 21, resulting in discernible variations in cognitive and physical characteristics. Finger gnosis pertains to the capacity to identify and discriminate among individual fingers. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Bin therapy and finger gnosia and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 14 May 2024to 20 Aug 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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range between 5-13 years
- Children with Down syndrome who are able to follow simple instructions.
- Medically stable participants can participate in therapeutic procedures.
- Participants and their families should be able to attend Bin Therapy weekly.
Who cannot join
- Any other medical conditions or cognitive impairments that could affect their participation in the study.
- History of seizures.
- History of heart problems
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 Bin Therapy on Finger Gnosia and Fine Motor Skills in Children With Down Syndrome
Down syndrome is a hereditary disorder resulting from the occurrence of an additional copy of chromosome 21, resulting in discernible variations in cognitive and physical characteristics. Finger gnosis pertains to the capacity to identify and discriminate among individual fingers. Tactile perception and body awareness are both encompassed by this particular component. Finger gnosis encompasses the sensory and cognitive mechanisms that enable an individual to recognize, label, and differentiate between their own fingers and those belonging to others. The therapeutic approach known as BIN Therapy is a non-invasive and pharmacologically unassisted intervention that use electrical stimulation as a means to enhance manual dexterity in individuals afflicted with neurological conditions
Read the detailed description
It will be a randomized controlled trial. 30 patients fulfilling the inclusion and exclusion criteria will be recruited by non-probability convenience sampling and then randomly divided in two groups using lottery method. Group A will receive will receive conventional physical therapy exercise program including core strengthening, balance and coordination exercise, fine motor skills activities with 2-3 times a week, with 20-50 minutes of each session with each set comprises of 10-12 repetitions of each exercise. And the group B will receive BIN therapy and finger gnosia. Sensory assessment will be assess by Revised Nottingham sensory assessment.
- Conditions
- Down Syndrome
- Being tested
- Bin therapy and finger gnosia, conventional therapy
- Keywords
- down syndrome, bin therapy, freely box activties, finger gnosia
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bin therapy and finger gnosiaOther
Schedule bin therapy sessions 2-3 times per week at first, increasing the frequency as participants get used to it. Data will be collected twice i.e., at the start of the study and after completion of 6 weeks of treatment by using outcome measure tools
conventional therapyOther
schedule conventional therapy with 20-50 minutes of each session with each set comprises of 10-12 repetitions of each exercise
| Study group | Role | What they receive |
|---|---|---|
| conventional physical therapy | Experimental | Control Group Receives: Other: conventional therapy |
| bin therapy and finger gnosia | Experimental | Experimental Group Receives: Other: Bin therapy and finger gnosia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger Gnosia Assessed by Vernier Caliper
Finger gnosia assessed by vernier caliper by two-point discrimination test. 2-5 mm average score, 6-10 mm mild impairment, 11-15 moderate impairment, 16 mm or above severe impairment
Measured: baseline and 8th week
Secondary outcomes (1)
Nottingham sensory assessment
tactile sensation 42 max score, proprioception and Kinesthesia 24 max score, total score 66- 0-20 severe sensory impairment, 21-40 moderate sensory impairment, 41-54 mild sensory impairment, 55 - 66 normal sensory function
Measured: baseline and 8th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start14 May 2024
- Primary completion17 Aug 2024
- Study completion20 Aug 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.
- 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 age 6-12 will be formed in which participants will be randomly divided. Group A will receive conventional physical therapy exercise program including core strengthening, balance and coordination exercise, fine motor activities and group b will receive BIN therapy and finger gnosia
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafsa Yasin, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576206
- Sponsor's protocol ID
- REC/RCR&AHS/23/0798
- Status last verified
- Sep 2024
- First submitted
- 11 Jun 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fischer U, Suggate SP, Stoeger H. Fine motor skills and finger gnosia contribute to preschool children's numerical competencies. Acta Psychol (Amst). 2022 Jun;226:103576. doi: 10.1016/j.actpsy.2022.103576. Epub 2022 Apr 4.
PubMed 35390583
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bin Therapy on Finger Gnosia and Fine Motor Skills in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06576206
- Acronym / sponsor ID
- REC/RCR&AHS/23/0798
- Conditions
- Down Syndrome
- Keywords
- down syndrome, bin therapy, freely box activties, finger gnosia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 28 Aug 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 is a hereditary disorder resulting from the occurrence of an additional copy of chromosome 21, resulting in discernible variations in cognitive and physical characteristics. Finger gnosis pertains to the capacity to identify and discriminate among individual fingers. Tactile perception and body awareness are both encompassed by this particular component. Finger gnosis encompasses the sensory and cognitive mechanisms that enable an individual to recognize, label, and differentiate between their own fingers and those belonging to others. The therapeutic approach known as BIN Therapy is a non-invasive and pharmacologically unassisted intervention that use electrical stimulation as a means to enhance manual dexterity in individuals afflicted with neurological conditions
Detailed description
It will be a randomized controlled trial. 30 patients fulfilling the inclusion and exclusion criteria will be recruited by non-probability convenience sampling and then randomly divided in two groups using lottery method. Group A will receive will receive conventional physical therapy exercise program including core strengthening, balance and coordination exercise, fine motor skills activities with 2-3 times a week, with 20-50 minutes of each session with each set comprises of 10-12 repetitions of each exercise. And the group B will receive BIN therapy and finger gnosia. Sensory assessment will be assess by Revised Nottingham sensory assessment.
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 age 6-12 will be formed in which participants will be randomly divided. Group A will receive conventional physical therapy exercise program including core strengthening, balance and coordination exercise, fine motor activities and group b will receive BIN therapy and finger gnosia
| Arm | Type | Receives |
|---|---|---|
| conventional physical therapy | Experimental | Other: conventional therapyControl Group |
| bin therapy and finger gnosia | Experimental | Other: Bin therapy and finger gnosiaExperimental Group |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age range between 5-13 years
- Children with Down syndrome who are able to follow simple instructions.
- Medically stable participants can participate in therapeutic procedures.
- Participants and their families should be able to attend Bin Therapy weekly.
Key exclusion criteria (3 listed)
- Any other medical conditions or cognitive impairments that could affect their participation in the study.
- History of seizures.
- History of heart problems
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 |
|---|---|---|
| Bin therapy and finger gnosiaSchedule bin therapy sessions 2-3 times per week at first, increasing the frequency as participants get used to it. Data will be collected twice i.e., at the start of the study and after completion of 6 weeks of treatment by using outcome measure tools | Other | bin therapy and finger gnosia |
| conventional therapyschedule conventional therapy with 20-50 minutes of each session with each set comprises of 10-12 repetitions of each exercise | Other | conventional physical therapy |
Primary outcome
Finger Gnosia Assessed by Vernier Caliper
Time frame: baseline and 8th week
Finger gnosia assessed by vernier caliper by two-point discrimination test. 2-5 mm average score, 6-10 mm mild impairment, 11-15 moderate impairment, 16 mm or above severe impairment
1 secondary outcome
Nottingham sensory assessment
Time frame: baseline and 8th weeks
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 4 Sep 2024.
- Background: PubMed 35390583Fischer U, Suggate SP, Stoeger H. Fine motor skills and finger gnosia contribute to preschool children's numerical competencies. Acta Psychol (Amst). 2022 Jun;226:103576. doi: 10.1016/j.actpsy.2022.103576. Epub 2022 Apr 4.
- Individual participant dataSharing planned: No
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Down Syndrome
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.
Hafsa Yasin, 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 Bin therapy and finger gnosia and conventional therapy 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 4 inclusion and 3 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 4 Sep 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?
Finger Gnosia Assessed by Vernier Caliper (time frame: baseline and 8th week). 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 NCT06576206, 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 4 Sep 2024.