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CTRI Number  CTRI/2024/03/064376 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Art Therapy and Grip Strengthening Exercises on grip strength and precision in Children with Intellectual Disability 
Scientific Title of Study   Effect Of Art Therapy and Grip Strengthening exercises on hand function in children with intellectual disability – A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Pramod Deore 
Designation  PG student 
Affiliation  Dr.A.P.J Abdul Kalam College of Physiotherapy 
Address  504, Department of Paediatric physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09075755334  
Fax    
Email  aditideore01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejas Borkar PT 
Designation  Associate Professor 
Affiliation  Dr.A.P.J Abdul Kalam College of Physiotherapy 
Address  504, Department of Paediatric physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09371271752  
Fax    
Email  tejasborkar57@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejas Borkar PT 
Designation  Associate Professor 
Affiliation  Dr.A.P.J Abdul Kalam College of Physiotherapy 
Address  504, Department of Paediatric physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09371271752  
Fax    
Email  tejasborkar57@gmail.com  
 
Source of Monetary or Material Support  
Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni,413736 
 
Primary Sponsor  
Name  Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS , Loni 
Address  Pravara Institute of Medical Sciences, Dr. A.P.J Abdul Kalam College of Physiotherapy , Loni, 413736 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aditi Pramod Deore  Dr. A.P.J Abdul Kalam College of Physiotherapy  Pravara Institute of Medical Sciences, Dr. A.P.J Abdul Kalam College of Physiotherapy , Loni, 413736
Ahmadnagar
MAHARASHTRA 
09075755334

aditideore01@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: F70||Mild intellectual disabilities, (2) ICD-10 Condition: F71||Moderate intellectual disabilities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Art therapy   Group A: Experimental group- Art Therapy + Conventional PT INTERVENTION: Week 1: session 1- Coloring with crayons+ Conventional PT Three shapes of triangle, square, and circle will be drawn by the tester. The children painted with contrasting colors (green-red), (yellow-purple), (blue-orange), (black-white) Session 2 - Finger painting+ Conventional PT Children will use paints and dip fingers to imprint it on a paper to make trees, birds and hand prints Session 3 – Sponge painting + Conventional PT Children will use sponge and paints to fill colors in a drawing Week 2: session 4 –Thread Painting + Conventional PT Children will be asked to dip threads of different girth in paint and use it on the paper Session 5 – Copying lines+ Conventional PT Children will be asked to copy vertical horizontal & diagonal lines Session 6 – Copying shapes and coloring with crayon+ Conventional PT Children will be asked to copy basic shapes Week 3- Session 7¬- Copying complex shapes + Conventional PT Session 8 – Coloring with brush + Conventional PT Session 9- Folding paper + Conventional PT Week 4 – Session 10- Cereal drawing + Conventional PT Session 11- Cutting out shapes+ Conventional PT Session 12- Session 11+ Putting Stickers on their belongings+ Conventional PT  
Comparator Agent  Conventional Therapy.  Week 1- Session 1- grasp lager object x 10 reps Session 2- crumble paper x 10 reps Session 3- ring set x 10 reps Week 2- Session 1- building tower x 10 reps Session 2- holding paper with one hand x 10 reps Session 3- turning pages of book x 10 reps Week 3- Session 1- unscrew jar lid x 10 reps Session 2- holding pen of different girth x 10 reps Session3- scribbling with different girth pens x 10 reps Week 4- Session 1- zipping /unzipping x 10 reps Session 2-separating smaller beads x 10 reps Session 3- buttoning/ unbuttoning x 10 reps  
Intervention  Grip strengthening exercises  Group B: Experimental group - Grip strengthening exercises+ Conventional PT Thera putty exercises : Week 1 - Session 1- power grip + Conventional PT Session 2- finger spread exercises + Conventional PT Session 3- Pancake spread + Conventional PT Week 2 - Session 1- Putty rolls + Conventional PT Session 2 -Hide and seek + Conventional PT Session 3-Fit the container + Conventional PT Week 3- Session 1 - Mix it up + conventional PT Session2 - Making shapes + conventional PT Session 3 -Three finger pinch + conventional PT Week 4- Session 1- Finger press + conventional PT Session 2- scissor fingers + conventional PT Session 3- Free play + conventional PT  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1 Children with mild and moderate intellectual disability according to DSM IV criteria.
2 Aged between 6 to 16 years
3 Males and females
4 Children with mean standard score of less than 50 (each subtest) on BOT 2 short form
5 Children with weak grip strength according to age appropriate normative data.
 
 
ExclusionCriteria 
Details  1 Participants whose parents are not willing to give written informed consent.
2 Children having musculoskeletal injury of hand since past 6 months
3 Children having visual or auditory impairments.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Bruininks-Oseretsky test - 2   week 0 and week 4 
 
Secondary Outcome  
Outcome  TimePoints 
Pinch strength using pinch Gauge  week 0 and week 4 
Hand Grip strength using Hand held Dynamometer  week 0 and week 4 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   28/03/2024 
Date of Study Completion (India) 31/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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

Intellectual disability (ID) is a neurodevelopmental disorder characterized by 3 features that is deficits in cognition, deficits in adaptive function, and onset during the developmental period1. Estimates of intellectual disability range between 1–3%, with a male to female ratio of 1.6:1 2. Causes of ID include genetic abnormalities, as well as prenatal, perinatal, and postnatal environmental factors3. The summary prevalence of ID in India was established to be 2% taking into consideration the individual prevalence studies over the last six decades4. Intellectual disability (ID) is characterized by significant impairment in cognitive and adaptive behaviour. The term used to describe this condition has gone under constant change over the years due to social and political compulsions.

These children are slow in reaching developmental milestones later than the normal children. In most individuals with intellectual disabilities, the parts of the brain continue to develop that is not damaged. Therefore, they continue to acquire skills and abilities as they grow older. It is often noted that brain damage causes a delay in development causing skill deficits in some form. When training support is extended in early years and links are strengthened between home and school adequately, then training effects sustain for a longer duration.

Intellectual disability is not a mental illness. Mental illness can occur at any age whereas intellectual disability is present from childhood.5 The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-1V)5 has classified four different degrees of intellectual disabilities as Mild intellectual disability (IQ 50–69), Moderate intellectual disability (IQ 35–49), Severe intellectual disability (20–35), Profound intellectual disability (20–35).6Well-developed fine motor skills facilitate children’s cognition and attention development and contribute positively to daily life activities.7

The American Art Therapy Association (AATA) defines art therapy as a mental health profession in which clients, facilitated by the art therapist, use artistic media, the creative process and the resulting artwork to explore their feelings, reconcile emotional conflicts, foster self-awareness, manage behavior and addictions, develop social skills, improve orientation in reality, reduce anxiety and increase self-esteem8. By way of hand-brain coordination, this therapeutic approach is conducive to maintaining and developing a patient’s coordination and motor skills and strengthening their fine motor skills9.

Nonspecific conventional exercises can be monotonous for the patients, whereas art therapy can be equally effective and interesting as it encourages patients by creating varied opportunities that revolve around tasks and activities which help them improve their hand function10. Theraputty exercise is a form of finger and grip strength training. It can be formed into various shapes, providing a well-balanced exercise program. Theraputty delivers a simple and effective resistance based training which helps to develop a strong, capable grip11.

NEED FOR THE STUDY:

Intellectual disabilities (ID) in children often present challenges that extend beyond cognitive functioning, affecting various aspects of their daily lives, including motor skills and hand function. While interventions targeting hand function are crucial for enhancing the overall quality of life in these individuals, the optimal approach remains uncertain.

Two potential interventions, namely art therapy and grip strengthening exercises, have shown promise in addressing hand function difficulties in children with intellectual disabilities. However, a comprehensive and comparative examination of the effectiveness of these interventions is lacking in current literature.

Art therapy, characterized by creative expression through artistic mediums, has been proposed as a therapeutic intervention that may enhance fine motor skills and hand-eye coordination. On the other hand, grip strengthening exercises, focusing on physical activities to enhance hand strength and dexterity, have also demonstrated positive outcomes in various populations.

The need for this study arises from the lack of clear evidence comparing the efficacy of art therapy and grip strengthening exercises specifically in children with intellectual disabilities. Understanding which intervention yields superior outcomes in terms of hand function will not only contribute to the advancement of evidence-based practices but also guide healthcare professionals, educators, and parents in making informed decisions regarding the most effective intervention for children with intellectual disabilities.

Moreover, identifying the more effective intervention will have significant implications for resource allocation and intervention planning, ultimately improving the overall well-being and functional abilities of children with intellectual disabilities. This study aims to bridge existing gaps in the literature and provide valuable insights that can inform clinical practice and contribute to the optimal care and support of this vulnerable population.

RESEARCH QUESTION

Is there a difference in the effectiveness of art therapy and grip strengthening exercises on hand function in children with intellectual disability?

AIM AND OBJECTIVES

AIM:

To find the effect of art therapy and grip strengthening exercises on hand function of children with intellectual disability.

 

OBJECTIVES:

1.     To investigate the impact of art therapy on hand function among children with intellectual disabilities using Bruininks-Oseretsky test - 2, pinch gauge and handheld dynamometer.

2.     To find the efficacy of grip strengthening exercises on hand function of children with intellectual disability using Bruininks-Oseretsky test - 2, pinch gauge and handheld dynamometer.

3.     To compare the effectiveness of art therapy and grip strengthening exercises on hand function of children with intellectual disability

Hypotheses

Null Hypothesis (H0):

There is no significant difference in the effect of art therapy and grip strengthening exercises on hand function in children with intellectual disability.

Alternative Hypothesis (H1):  

There is significant difference in the effect of art therapy and grip strengthening exercises on hand function in children with intellectual disability.

MATERIAL AND METHODOLOGY

Study Setting:  Department of Pediatric Physiotherapy, Dr. A.P.J Abdul Kalam college of physiotherapy, Loni & Special schools around Loni.

Study Type: Experimental study.

Study Design:  Randomized controlled trial

Study Duration: 2 years

Sampling Method: Simple Random Sampling


OUTCOME MEASURES

Outcome measures used for this study will be as follows,

1.     Bruininks-Oseretsky test - 2 (r =0.88)

2.     Hand held Dynamometer (test retest reliability 0.78-0.85)

3.     Pinch Gauge (r= 0.78-0.82)


ELIGIBLITY CRITERIA:

Inclusion criteria:

Ø  Children with mild and moderate intellectual disability according to DSM IV criteria.

Ø  Aged between 6 to 16 years

Ø  Males and females

Ø  Children with mean standard score of < 50 (each subtest) on BOT 2 short form

Ø  Children with weak grip strength according to age appropriate normative data.

 

Exclusion criteria:

Ø  Participants whose parents are not willing to give written informed consent.

Ø  Children having musculoskeletal injury of hand since past 6 months

Ø  Children having visual or auditory impairments.

PROCEDURE

Protocol is prepared and ethical clearance will be obtained from the IEC.

The Participants will be selected based on the eligibility criteria.

Informed consent will be obtained from the caregivers of the participants and demographic data will be recorded.

 Participants will be randomly allocated to 3 groups that is experimental group A (n=12), experimental group B (n=12) and control group (n= 12). Prior assessment of the participants will be done.

Experimental group ‘A’ will be administered with Art therapy and conventional treatment and group ‘B’ with Grip strengthening training along with conventional physiotherapy and control group ‘C’ will be administered with conventional treatment for hand functions.

The participants will be given exercise regimen and administered to perform for 30 mins per session for 3 days in a week for 4 weeks.

The hand functions will be measured with Bruininks-Oseretsky test - 2, Hand held Dynamometer and Pinch Gauge.

Statistical analysis will be done and result will be calculated.

REFERENCES

 

1.     American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th. Arlington, VA: American Psychiatric Association; 2013.

2.      Leonard H, Wen X. The epidemiology of mental retardation: challenges and opportunities in the new millennium. Ment Retard Dev Disabil Res Rev. 2002;8(3):117–34

3.     Toth K, deLacy N, King BH. Intellectual disability. In: Dulcan MK, editor. Dulcan’s textbook of child and adolescent psychiatry. 2nd 2016. 

4.     Russell PSS, Nagaraj S, Vengadavaradan A, Russell S, Mammen PM, Shankar SR, Viswanathan SA, Earnest R, Chikkala SM, Rebekah G. Prevalence of intellectual disability in India: A meta-analysis. World J Clin Pediatr. 2022 Mar 9;11(2):206-214. doi: 10.5409/wjcp.v11.i2.206. PMID: 35433303; PMCID: PMC8985497.

5.     R. Kalgotra, J.S. Warwal. Intellectual Disability in India: An overview. J. Disability Stud., 2017, 3(1), 1-8.

6.     American Psychiatric Association. Mental retardation, In Diagnostic and Statistical Manual of Mental Disorders, 4 th ed., text revision, Washington, DC: American Psychiatric Press, Inc, 2000.

7.     Pitchford, N. J., Papini, C., Outhwaite, L. A. and Gulliford, A. 2016. Fine motor skills predict maths ability better than they predict reading ability in the early primary school years. Frontiers in Psychology, 7, 783.

8.     5. American Art Therapy Association. Definition Statement. 2014.08.20.

9.     Wang Q-Y, Li D-M. Advances in art therapy for patients with dementia. Chin Nurs Res. 2016;3:105e108.

10.  Hajar R. Art and Healing. Heart Views 2015;16:116‑7

1.     Wakpaijan KR, Shende M. Comparative study of two resisted exercise for the improvement of grip strength in dentist. Int J Multidiscip Res Dev 2017;4:131-6.s












 
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