Visual ImpairmentNCT06197607
Effect of Hand Exercises on Hand Grip Strength and Manual Ability in Children With Visual Impairment
A study testing theraputty hand exercises and sensory stimulation in people with Visual Impairment, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Visual Impairment
- What is being tested?
- theraputty hand exercises and sensory stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Nov 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Visual Impairment
- Being tested
- theraputty hand exercises, sensory stimulation
- Keywords
- Hand grip strength, Sensory stimulation, Visual impairment
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theraputty hand exercisesOther
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 stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | The control group will receive thera putty hand exercises. Receives: Other: theraputty hand exercises |
| experimental group | Active comparator | The experimental group will receive sensory stimulation along with theraputty hand exercises. Receives: Other: theraputty hand exercises; Other: sensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start28 Nov 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Areej Aslam, Ms, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197607
- Sponsor's protocol ID
- REC/RCR & AHS/23/0740
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hand Exercises With and Without Sensory Stimulation on Hand Grip Strength and Manual Ability in Children With Visual Impairment
- ClinicalTrials.gov ID
- NCT06197607
- Acronym / sponsor ID
- REC/RCR & AHS/23/0740
- Conditions
- Visual Impairment
- Keywords
- Hand grip strength, Sensory stimulation, Visual impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: theraputty hand exercisesThe control group will receive thera putty hand exercises. |
| experimental group | Active comparator | Other: theraputty hand exercises, Other: sensory stimulationThe experimental group will receive sensory stimulation along with theraputty hand exercises. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| theraputty hand exercisesTheraputty 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 | Other | control group, experimental group |
| sensory stimulationSensory 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. | Other | experimental group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- BackgroundShaikh 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areej Aslam, Ms principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing theraputty hand exercises and sensory stimulation in people with Visual Impairment, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Block Test (BBT) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.