NCT06576206

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

June 11, 2024

Last Update Submit

September 3, 2024

Conditions

Keywords

down syndromebin therapyfreely box activtiesfinger gnosia

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline and 8th week

Secondary Outcomes (1)

  • Nottingham sensory assessment

    baseline and 8th weeks

Study Arms (2)

conventional physical therapy

EXPERIMENTAL

Control Group

Other: conventional therapy

bin therapy and finger gnosia

EXPERIMENTAL

Experimental Group

Other: Bin therapy and finger gnosia

Interventions

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

bin therapy and finger gnosia

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

conventional physical therapy

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Any other medical conditions or cognitive impairments that could affect their participation in the study.
  • History of seizures.
  • History of heart problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 35390583BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Hafsa Yasin, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will get separate treatment protocols and possible efforts will be put to mask the the both group about treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

August 28, 2024

Study Start

May 14, 2024

Primary Completion

August 17, 2024

Study Completion

August 20, 2024

Last Updated

September 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations