- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06576206
Effects of Bin Therapy on Finger Gnosia And Fine Motor Skill
September 3, 2024 updated by: Riphah International University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Any other medical conditions or cognitive impairments that could affect their participation in the study.
- History of seizures.
- History of heart problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: conventional physical therapy
Control Group
|
schedule conventional therapy with 20-50 minutes of each session with each set comprises of 10-12 repetitions of each exercise
|
|
Experimental: bin therapy and finger gnosia
Experimental Group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline and 8th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nottingham sensory assessment
Time Frame: baseline and 8th weeks
|
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
|
baseline and 8th weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hafsa Yasin, MS, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2024
Primary Completion (Actual)
August 17, 2024
Study Completion (Actual)
August 20, 2024
Study Registration Dates
First Submitted
June 11, 2024
First Submitted That Met QC Criteria
August 27, 2024
First Posted (Actual)
August 28, 2024
Study Record Updates
Last Update Posted (Actual)
September 4, 2024
Last Update Submitted That Met QC Criteria
September 3, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0798
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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