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OpenTrials
Completed

NCT Number: NCT06576206

Effects of Bin Therapy on Finger Gnosia And Fine Motor Skill

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

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bin therapy and finger gnosia

Other

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 Therapy

Other

schedule conventional therapy with 20-50 minutes of each session with each set comprises of 10-12 repetitions of each exercise

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Bin Therapy on Finger Gnosia and Fine Motor Skills in Children With Down Syndrome

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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