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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06197607
Other study ID # REC/RCR & AHS/23/0740
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 28, 2023
Est. completion date February 5, 2024

Study information

Verified date January 2024
Source Riphah International University
Contact Imran Amjad, phd
Phone 033224390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date February 5, 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
theraputty hand exercises
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
sensory stimulation
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.

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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