- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06197607
Effect of Hand Exercises on Hand Grip Strength and Manual Ability in Children With Visual Impairment
Effect of Hand Exercises With and Without Sensory Stimulation on Hand Grip Strength and Manual Ability in Children With Visual Impairment
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: control group
The control group will receive thera putty 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
|
|
Active Comparator: experimental group
The experimental group will receive sensory stimulation along with 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and Block Test (BBT)
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Areej Aslam, Ms, Riphah International University
Publications and helpful links
General Publications
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0740
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Visual Impairment
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven; University Ghent; Research Foundation Flanders; Free University of Brussels and other collaboratorsUnknowniVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment (iVision)Visual Perceptual Weakness (Disorder) | Cerebral Visual ImpairmentBelgium
-
National Taiwan University HospitalRecruitingCerebral Visual Impairment | Visual Rehabilitation | Oddball Design | Passive Visual Stimulation | Perceptual LearningTaiwan
-
Novartis PharmaceuticalsCompletedNeovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNVGermany
-
Universitaire Ziekenhuizen KU LeuvenVrije Universiteit Brussel; Fund for Scientific Research, Flanders, BelgiumCompletedCerebral Visual ImpairmentBelgium
-
Russell L. WoodsResearch to Prevent Blindness / Lions Club International FoundationNot yet recruitingCentral Visual Impairment
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Clinique Rive GaucheCompletedVisual Impairment in ChildrenFrance
-
Nantes University HospitalTerminatedCentral or Peripheral Visual ImpairmentFrance
-
VA Office of Research and DevelopmentCompletedScotoma, Central | Central Visual ImpairmentUnited States
Clinical Trials on theraputty hand exercises
-
Akdeniz UniversityNot yet recruitingOlder Adults (65 Years and Older)Turkey (Türkiye)
-
Akdeniz UniversityCompleted
-
Gulhane Training and Research HospitalCompletedColorectal Cancer | Chemotherapy-induced Peripheral NeuropathyTurkey
-
Riphah International UniversityRecruitingMedian Nerve InjuryPakistan
-
Riphah International UniversityCompleted
-
Taipei Veterans General Hospital, TaiwanNot yet recruitingCervical Cancer | Ovarian Cancer | Endometrial Cancer | Peripheral Neuropathy | Vaginal Cancers | Fallopian Tube CancersTaiwan
-
Amany Refaat Mohamed Abdel WahidCairo UniversityCompleted
-
Hôpital FribourgeoisRecruitingDistal Radius FractureSwitzerland
-
Istanbul UniversityCompletedScleroderma, Systemic | Rehabilitation | Physiotherapy | Scleroderma | Hand Rheumatism | Scleroderma Associated Digital UlcerTurkey
-
Odense University HospitalUniversity of Southern Denmark; Region of Southern Denmark; Bevica Fonden; Danish...CompletedHand Related InjuriesDenmark