NCT06197607

Brief Summary

Development of the visual system immediately starts after birth via visual stimuli and interactions with the environment. The World Health Organization (WHO) has categorized visual impairments with respect to the best-corrected visual acuity as follows: blindness (Snellen visual acuity of 3/30), severe visual impairment (Snellen visual acuity between 6/60 and 3/30), moderate visual impairment (Snellen visual acuity between 6/18 and 6/60), and mild or no visual impairment (Snellen visual acuity of 6/18). The proper function of hands, particularly in delicate activities, depends on the interaction between the various regions of the brain, particularly, the sensory and motor cortex. Sensory stimulation can be used in such children to improve their manual dexterity and therapeutic interventions can be applied to gain hand strength. Developing skillful hands is a necessity in blind children as it often compensates for their missing vision. This study will focus on effectiveness of hand grip strength and manual ability with sensory stimulation in children with moderate to severe visual impairment. Theraputty hand exercises and sensory stimulation techniques will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

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

November 28, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

Hand grip strengthSensory stimulationVisual impairment

Outcome Measures

Primary Outcomes (2)

  • Box and Block Test (BBT)

    A rectangular box divided into 2 compartments by a wooden partition is in front of the individual, and 150 coloured wooden blocks are placed in one compartment. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for the duration of 60 seconds. Approximately 5 minutes are required for set up, explanation of the instructions to the patient and administration of the test. Stopwatch,Wooden box with partition (box: 53.7 x 25.4 x 8.5 cm, partition: 25.4 cm x 15.2 cm x 1 cm), 150 wooden blocks (2.5 cm cubed). Scored by counting the number of blocks carried over by the individual from one compartment to the other. If the individual carries multiple blocks over at a time, this only counts as 1 point.If the individual brings the block over the partition and drops it outside of the box, the block still counts.

    12 weeks

  • Hand Dynamometer

    : most widely reported device used to measure grip strength. It displays grip force in both pounds and kilograms, with a maximum of 200 lb (90 kg). Handheld dynamometer can ensure quantified strength measurement and clinically, it is very effective and efficient tool. It is also considered as a reliable and valid tool to measure the strength of muscles in the upper and lower extremities. intra-rater (ICC 2, k = 0.95 to 0.97) and inter-rater (ICC 2, k = 0.94 to 0.95) reliability.

    12 weeks

Study Arms (2)

control group

OTHER

The control group will receive thera putty hand exercises.

Other: theraputty hand exercises

experimental group

ACTIVE COMPARATOR

The experimental group will receive sensory stimulation along with theraputty hand exercises.

Other: theraputty hand exercisesOther: sensory stimulation

Interventions

Theraputty hand exercises will be done in following manners: Finger flexion, Metacarpophalangeal joint flexion, Interphalangeal joint flexion, Finger grip strengthening, Finger abduction and Rolling putty into ball and pinching it between, thumbs and finger with both the hands. There will be 20 repetitions with one set of each

control groupexperimental group

Sensory Stimulations (30 min) will be given following forms; All and single joint shaking, Multivariate sensory stimulations, Skin stretch in the muscular region, Fast stretch of the upper limb joints in different directions of motor action, brushing on the large muscles of arm and forearm, brushing on the fingers, Circular massage of the thenar and hypothenar area and pressing the tip of fingers.

experimental group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with moderate (Snellen visual acuity between 6/18 and 6/60) to severe (Snellen visual acuity between 6/60 and 3/30) congenital visual impairment. (9)
  • Children diagnosed with bilateral congenital visual impairment. (9)
  • No prior exposure to therapeutic interventions given to hands. (9)
  • Children who can understand English or regional Urdu language. (9)
  • Children aged above 6-12 years (9)
  • Children of either gender will be included.

You may not qualify if:

  • Children with any orthopedic problem related to hand. (9)
  • Children who went through any surgery of hands or eyes. (9)
  • Children with any neurological issues related to hand. (9)
  • Those who were unable to communicate or unable to hear well .(5).
  • Children diagnosed with complete blindness (Snellen visual acuity of 3/30) .(5).
  • Non-co-operative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

  • Shaikh S. Effect of hand exercises on grip strength and manual dexterity in children with severe congenital visual impairment. Indian Journal of Child Health. 2020;7:477-9

    BACKGROUND

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Areej Aslam, 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 effort will be put to mask the both groups about their treatment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomised control trial will be conducted with sample size 20. 20 participants will be included in the study. There will be 10 individuals who will receive hand exercises along with sensory stimulation to improve hand grip strength and manual ability and 10 Individuals who will only receive hand exercises to improve hand grip strength and manual ability. Grip strength and will be analyzed using hand dynamometer. For manual dexterity, box and block test will be used. Grip strength and manual dexterity will be analyzed before and after the intervention.Group A individuals will only receive hand exercises to improve hand grip strength and manual ability. Group B individuals will receive hand exercises along with sensory stimulation to improve hand grip strength and manual ability.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

November 28, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations