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CTRI Number  CTRI/2024/12/078054 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Impact of an Eye-Hand Coordination Device on Upper Limb Function in Stroke Patients 
Scientific Title of Study   The Effect of an Eye-Hand Coordination Device on Upper Limb Motor Coordination in Patients with Stroke 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhuvendra Pandey 
Designation  student  
Affiliation  Pravara Institute Of Medical Sciences  
Address  Dr. APJ Abdul Kalam College of Physiotherapy,303 Neurophysiotherapy department Pravara Institute of Medical Sciences, Loni,Ahmadnagar,413736 MAHARASHTRA,India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7726854908  
Fax    
Email  neetcracker720@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ketaki Patani PT 
Designation  Assosciate Professor 
Affiliation  Pravara Institute Of Medical Sciences  
Address  Dr. APJ Abdul Kalam College Of Physiotherapy,303 Neurophysiotherapy department loni, Ahmadnagar MAHARASHTRA 413736 India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9168022254  
Fax    
Email  ketu6731@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Madhuvendra Pandey 
Designation  student 
Affiliation  Pravara Institute Of Medical Sciences 
Address  Dr. APJ Abdul Kalam College of Physiotherapy,303,Neurophysiotherapy department Pravara Institute of Medical Sciences, Loni, Ahmadnagar,413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7726854908  
Fax    
Email  neetcracker720@gmail.com  
 
Source of Monetary or Material Support  
Dr. APJ Abdul Kalam College of Physiotherapy,Pravara Institute of Medical Sciences, Loni,Ahmadnagar,413736 MAHARASHTRA,India 
 
Primary Sponsor  
Name  Dr APJ Abdul Kalam College Of Physiotherapy 
Address  Pravara Institute Of Medical Sciences ,Dr APJ Abdul Kalam College Of Physiotherapy Loni 413736 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr APJ Abdul Kalam College Of Physiotherapy  Pravara Institute Of Medical Sciences ,Dr APJ Abdul Kalam College Of Physiotherapy Loni 413736 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Madhuvendra Pandey  Dr. A.P.J Abdul Kalam College of Physiotherapy, loni, Ahmadnagar  Pravara Institute Of Medical Sciences ,Dr APJ Abdul Kalam College of Physiotherapy,303,Neurophysiotherapy Loni, 413736, Ahmednagar
Ahmadnagar
MAHARASHTRA 
7726854908

neetcracker720@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Dr. APJAK COPT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CONVENTIONAL THERAPY  1)FRENKELS EXERCISES for upper extremity 2)Target practice 3)Wall ball bounce Week 1 to 2: - Frequency – 3 sessions / week Intensity – moderate Time – 30 minutes (3 sets of 10 repetitions) Type – task oriented exercise Week 2 to 3: - Frequency – 3 sessions / week Intensity – moderate Time – 30 minutes (3 sets of 10 repetitions) Type – task oriented exercise  
Comparator Agent  EXPRIMENTAL THERAPY   1)Eye hand coordination device – participant will be in sitting position and is asked to hold the object of 2cm,3cm and as such. Week 3 to 4: - Frequency – 3 sessions / week Intensity – moderate Time – 30 minutes (3 sets of 10 repetitions) Type – Eye-Hand Coordination Task Week 5 to 6: - Frequency – 3 sessions / week Intensity: - moderate Time: - 30 minutes (3 sets of 10 repetitions) Type: - Eye-Hand Coordination Task Therapist will demonstrate the activity, the patient will be handed the hand piece and then asked to move from starting position to end position.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Both male and female population
2)Age between 40- 60 years
3)Diagnosed case of cerebrovascular accident
4)Individuals willing to sign the consent.
 
 
ExclusionCriteria 
Details  1)Disoriented individuals
2)Brain surgery due to any other reason
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)FMA UPPER EXTREMITY SCALE
2)NON-EQUILIBRIUM TEST
 
Week 0 to week 4
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   25/12/2024 
Date of Study Completion (India) 03/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 03/05/2025 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION:-

 A stroke is a clinically defined syndrome characterized by quickly emerging symptoms or indicators of focal loss of cerebral function, with no other apparent cause than vascular origin. However, the loss of function can occasionally be global (applied to patients with subarachnoid haemorrhage and deep coma). symptoms could be fatal or linger longer than 24 hours.1. The severity of the illness ranges from a full recovery in a single day to a severe handicap that requires lifelong care to death. The criteria has not changed in over 20 years, and there is no cause to change it in the near future, whether it is for epidemiological or clinical purposes. If the definition relied too much on technology—like brain imaging—epidologists wouldn’t be able to apply it .(1)

The main finding, which is surprising, is that haemorrhagic strokes, not ischemic ones, accounted for most stroke cases worldwide in 2010. A third (31·5%) of the 16·9 million incident stroke events (20% in high-income countries and 37% in low- and middle-income countries) were haemorrhagic strokes, an incidence rate that is greater than previously thought. Even so, hemorrhagic stroke accounted for three-quarters (61·5%) of the 102·2 million DALYs lost globally and over half (51·7%) of the 5·9 million stroke-related deaths, while being only half as common as ischemic stroke. Compared to ischemic stroke (mean age 65·1 years [SD 0·11]), which afflicted persons at a later age (73·1 years [0·10]), hemorrhagic stroke caused a greater number of years of life lost. (2)

The second important finding is that low-income and middle-income countries bear the majority of the burden of ischemic and hemorrhagic stroke, accounting for 63% of incident ischemic strokes and 80% of hemorrhagic strokes, 57% of ischemic stroke-related deaths and 84% of hemorrhagic stroke-related deaths, and 64% of DALYs lost as a result of ischemic stroke and 86% due to hemorrhagic stroke. (2)

The third finding indicates that individuals under 75 years of age carry the majority of the burden of ischemic and hemorrhagic stroke, accounting for 62% of incidence ischemic strokes and 78% of hemorrhagic strokes, as well as 63% of DALYs lost as a result of ischemic stroke and 83% owing to hemorrhagic stroke. (2)

The fourth finding shows that, between 1990 and 2010, there was a significant increase in the total number of people who had incident ischemic stroke (up 37%) and incident hemorrhagic stroke (up 47%), as well as a rise in the number of deaths from ischemic stroke (21%), hemorrhagic stroke (20%), and DALYs lost from ischemic stroke (18%) and hemorrhagic stroke (14%). The age-standardized incidence of both ischemic and hemorrhagic strokes has decreased by 13% and 19%, respectively. Stroke mortality rates have also decreased by 37% and 38%, and DALY rates for both types of strokes have decreased by 34% and 39%, respectively. Nevertheless, the absolute numbers have increased. (2)

Fifth, there has been a twenty-year increase in the incidence of hemorrhagic stroke in low- and middle-income countries (22% increase, 95% CI 5-30), with a notable increase in cases in those under 75 years of age (19%, 5-30). As a matter of fact, compared to high-income countries, low- and middle-income countries had greater rates of hemorrhagic stroke: 40% higher incidence, 77% higher mortality, and 65% higher DALY rates. (2)

The capacity to carry out precise, fluid, and regulated motor responses is known as coordination or coordinated movement. It is a difficult procedure that depends on a fullywhole neuromuscular system. The characteristics of coordinated motions include muscular tension, timing, distance traveled, direction, and speed. Physical therapists can access motor performance information through coordination assessments. They aid in determining the cause of motor impairments. Numerous observational coordination tests have been offered, and related research has been conducted. (3)

 

The ability to integrate and analyze touch and visual information in the central nervous system to enable intentional motor movements is known as eye-hand coordination. There exist two distinct components to eye-hand coordination. Validation Reaction (an open motor skill) and (a closed motor talent). Action that the athlete controls or initiates is referred to as probation. Movement that takes place in reaction to another activity is referred to as a reaction. The ability of the visual system to synchronize the information received through the eyes to control, lead, and mentally direct the hands in the completion of a specific action, such writing by hand or catching a ball, is known as hand-eye coordination. Hand-eye coordination involves using the hands to carry out an action and the eyes to focus attention. (4)

Patients who have had a stroke frequently struggle with hand-eye coordination, which impairs their finger dexterity and perception accuracy. These limitations may have a major effect on their general quality of life. In order to test upper limb impairment and coordination, a new eye-hand correlation evaluation system with improved assessment metrics is presented in this work. It correlates hand and arm movements with eye-gaze via a robotic haptic device. To quantify the displacement of upper limb joint angles, the experimental setup incorporates four inertial sensors, an eye tracker, and a haptic device. In a virtual world, the user makes different hand movement patterns as data is being simultaneously gathered from the hand, eye, and arm movements. The Pearson coefficient was used to generate the eye-hand coordination measure (EHCM), which was then associated with upper limb movements. (5)

NEED FOR STUDY-

stroke is very common and is caused by a lot of factors, which include a sedentary lifestyle, hypertension, smoking, stress, and head injury.

Stroke has a lot of repercussions, which include limb weakness, dropping of the eyelid,

Deviation of the mouth, difficulty speaking, and swallowing, especially in coordination

Due to impaired coordination, it causes disturbed eye-hand co-ordination, which causes difficulty in daily life for stroke survivors.

To check the effect of an experimental protocol on stroke patients in comparison with a conventional or traditional approach (protocol).

People with stroke have impaired co-ordinatiob and reduce upper extremity motor function some studies shows conventional protocol for improving coordination but there is paucity in the literature that includr combine effect of eyehand coordination device along with coordination exercises to improve in coordination in stroke surviors so this study is initiative approach to improve coordination in stroke surviours.

RESEARCH QUESTION-

 what is the effect of eye hand coordination device to improve coordination  in stroke surviours?

AIM- EFFICIENCY OF EYE-HAND COORDINATION TO ENHANCE MOTOR FUNCTION IN UPPER LIMB STROKE SURVIVORS


OBJECTIVES-

1)    To study the effect of eye hand co-ordination with eye hand devices

2)    To compare the effect of a conventional or traditional approach (protocol) with an experimental protocol on stroke patients.

HYPOTHESIS-

Null Hypothesis (H0): There is no significant EFFECT OF EYE-HAND COORDINATION DEVICETO ENHANCE CO-ORDINATION IN UPPER LIMB STROKE SURVIVORS – RANDOMIZED CONTROL TRIAL

 

Alternative Hypothesis(H1): There is a significant EFFECT OF EYE-HAND COORDINATION DEVICETO ENHANCE CO-ORDINATION IN UPPER LIMB STROKE SURVIVORS – RANDOMIZED CONTROL TRIAL

METHODOLOGY

1)    Source of Data: From Pravara Institute of Medical Sciences

2)    Study Setting: Study will be conducted in the out-patient department of Neuro physiotherapy department and department of medicine

3)    Study Duration: 6 week

4)    Study Design: Comparative study

5)    Target population:  MCA stroke survivors

6)    Sampling Method:  experimental study

7)    Sample Size: 50

8)    Tools and Materials Used: hand piece , wires , coins

 

 

 

SELECTION CRITERIA

Inclusion criteria:

9)    Both male and female population

10)  Age between 40- 60 years

11)  Diagnosed case of cerebrovascular accident

12)  Individuals willing to sign the consent.

.

 Exclusion criteria:

13)  Disoriented individuals

14)  Brain surgery due to any other reason

 Outcome measures:

 FMA UPPER EXTREMITY SCALE

  NON-EQUILIBRIUM TEST

PROCEDURE:

1)    Study design will be prepared prior to commencement of the study and ethical approval from IEC will be taken at Dr. APJ Abdul Kalam College Of  Physiotherapy.

2)    Send approval for randomized control trial.

3)    Samples will be identified according to exclusion and inclusion criteria

4)    Entire process will be explained to the sample and a written consent will be taken.

5)    The individuals will be divided into 2 groups FRENKELS EXE

6)    Group A will have 25 participants receiving Conventional treatment.

7)    Duration – 4 weeks, 4 days per week and treatment duration - 30 to 40 mins

Group B will have 25 participants receiving Experimental treatment.

 

GROUP A: CONVENTIONAL THERAPY

8)    Participants will be assessed for sensitivity.

9)    Partcipants will be explained about the procedure.

10)  FRENKELS EXERCISES for upper extremity

11)  Target practice

12)  Wall ball bounce

 

 

GROUP B: EXPRIMENTAL THERAPY

1)      Eye hand coordination device – participant will be in sitting position and ios asked to hold the object od 2cm,3cm and as such.

Therapist will demonstrate the activity, the patient will be handed the hand piece and then asked to move from starting position to end position.

  REF:

1.     Lodder J, Bamford JM, Sandercock PA, Jones LN, Warlow CP. Are hypertension or cardiac embolism likely causes of lacunar infarction? Stroke. 1990 Mar;21(3):375-81. doi: 10.1161/01.str.21.3.375. PMID: 2309260.

2.     Webb AJ, Fischer U, Mehta Z, Rothwell PM. Effects of antihypertensive-drug class on interindividual variation in blood pressure and risk of stroke: a systematic review and meta-analysis. Lancet. 2010 Mar 13;375(9718):906-15. doi: 10.1016/S0140-6736(10)60235-8. PMID: 20226989.

3.     Sheikh M, Kanase SB. The Effect of Eye-Hand Coordination Device on Coordination in Subjects with in-Coordination. Indian Journal of Public Health Research & Development. 2020 Jan 31;11(1):202-6.

4.     Nayak AK. Effect of hand-eye coordination on motor coordinative ability of tribal adolescents. International Journal of Physical Education, Sports and Health. 2015;2(2):328-30.

5.     D. Copaci, N. Pernalete, Á. G. Ortiz and D. B. Rojas, "Proposed Eye-Hand Correlation Assessment System: A Novel Approach for Evaluating Coordination," in IEEE Access, vol. 12, pp. 3926-3935, 2024, doi: 10.1109/ACCESS.2023.3349300.

6.     Abiodun A. Stroke (Cerebrovascular Accident (CVA) or brain attack) and its management-Literature review. Int J Innov Healthc Res. 2018;6:1-9.

O’Donnell MJ, Xavier D, Liu L, Zhang H, Chin SL, Rao-Melacini P, Rangarajan S, Islam S, Pais P, McQueen MJ, Mondo C, Damasceno A, Lopez-Jaramillo P, Hankey GJ, Dans AL, Yusoff K, Truelsen T, Diener HC, Sacco RL, Ryglewicz D, Czlonkowska A, Weimar C, Wang X, Yusuf S; INTERSTROKE investigators. Risk factors for ischaemic and intracerebral haemorrhagic stroke in 22 countries (the INTERSTROKE study): a case-control study. Lancet. 2010 Jul 10;376(9735):112-23. doi: 10.1016/S0140-6736(10)60834-3. Epub 2010 Jun 17. PMID: 20561675.


 
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