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Multidisciplinary Telerehabilitation Practices in Autism

Primary Purpose

Physiotherapy and Rehabilitation, Nutrition, Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
telerehabilitation exercise
Control Group
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physiotherapy and Rehabilitation focused on measuring Physiotherapy and Rehabilitation, Nutrition, Autism Spectrum Disorder, Telerehabilitation, Multidisciplinary

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Volunteering to participate in the study 6-11 years old child Have an approved medical diagnosis for Asperger's syndrome, autism, or a specific developmental disorder (DSM 5), by the standards set in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition Children with mild to moderate autism according to the childhood autism rating scale Not having received physical activity and nutrition counseling before Children with normal orally fed and functioning gastrointestinal tract Exclusion Criteria: Having any serious condition (such as orthopedic or any acute) for which it is contraindicated to the viewer of recreational entertainment programs Recent (less than 4 weeks) children on any psychotropic medication Those who have high-intensity activity according to the International Physical Activity Questionnaire (IPAQ) Children with chewing and swallowing difficulties You can enter as a child suitable for children. Children with diagnosed nutritional problems (absorption disorder, metabolic structure) have Gastroenterol patients suitable for medical intervention or bowel segments, Leukemia or other cancers, Hypothyroidism or other chronic conditions that can grow and turn into energy Acute myocarditis, active endocarditis, control eg missed heart probe, tachyarrhythmia, bradyarrhythmia, hypertrophic cardiomyopathy

Sites / Locations

  • Saglik Bilimleri Universitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation Group (TRG)

Conventional Rehabilitation Group (CRG)

Arm Description

The group given physical activity and nutrition counseling for 2 months through telerehabilitation.

The group who received conventional treatment and had no intervention, only pretest measurements

Outcomes

Primary Outcome Measures

Functional Independence Measure for Children (WeeFIM)
Functional Independence measure for children (WeeFIM) is an adaptation of the Functional Independence Measure (FIM) developed for adults. It is a useful, short and comprehensive measurement tool that detects the developmental, educational and social functional limitations of children with Cerebral Palsy and other developmental disorders. WeeFIM consists of 18 items in 6 areas The scores that can be obtained from the scale are between 18 and 126. The higher the score, the higher the child's independence. A higher score indicates positive improvement.
Quality of Life Questionnaire in Autism
It has been divided into two subsections (A and B). Part A contains 28 questions that measure how parents perceive their quality of life. Part B contains 20 questions that assess parents' perceptions of how much of a problem their child's autism-specific difficulties are for them. In the five-point Likert-type assessment measure, in which they evaluate how problematic these situations are for the parents, five are scored as 'It was not a problem for me at all', while one is scored as 'It was a lot of trouble for me'. The score that can be obtained from the scale is between 48-240. A high score indicates an improved quality of life.
Cornell musculoskeletal discomfort questionnaire
The questionnaire surveyed the frequency and severity of pain or discomfort in 11 different body regions (neck, shoulder, back, upper arm, wrist, forearm, wrist, hip, upper leg, knee, and lower leg) during the work period in the last week. assessing its impact on performance. For each body region, the weighted score of that body region is calculated by multiplying the ratings marked from the areas of frequency, severity, and effect on work performance. Scores for each region range from 0 to 90. A high score indicates that the region has a pain and disability.
Beck Depression Inventory
It is used to objectively determine the level of depression exhibited by individuals. Beck Depression Inventory includes 21 categories of depressive symptoms. Each of these categories consists of 4 items for self-assessment and is graded between 0 and 3 points.
6 minutes walking test
The 6-minute walk test measures the distance the patient can walk quickly on a flat, hard surface in a period of 6 minutes. It evaluates the integrated responses of all systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. The vital signs of the participants were taken before and after the test. The 6 minute walk test (6MWT) built in a 30 m-long straight corridor. The patient was asked to walk as much as they could, and the distance walked was recorded in meters.
Evaluation of Participation in Activities
In the study, with the form the investigators created to evaluate the participation of children with special needs in leisure activities, the demographic characteristics of the children, their educational status, the economic status of their families, the type and reason for their disability were asked to the families, which activities they wanted to do and what they did, the situations that prevented them from participating in the activities and the assistive tools they used were asked to the children. evaluated.
Evaluation of Family Role in Activity Participation
A form was created that included the questions of who decides the activities that the children will do, whether the families control them during the activity, whether the children are willing to participate in the activity and whether they can express the activity they participate in, to what extent the families approve of their children's ideas and to what extent they encourage their children to participate in the activities. the role was evaluated.
Childhood Autism Rating Scale
The Childhood Autism Rating Scale can be applied to children of all age groups starting from the preschool period. It is a 15-item scale that evaluates behaviors in 14 areas that are generally affected by serious problems in autism and a general impression category of autism. Each question has a rating of 1-4. It means mild autism between 15 and 29 points, moderate autism between 30 and 36 points and severe autism between 37 and 60 points.
Food Consumption Frequency Questionnaire
In order to determine the food consumption status of children with autism, it was applied to parents of children with an autism spectrum disorder. The questionnaire separates 5 food groups and includes the foods belonging to each food group under these groups. The frequency of food consumption was determined by the answer given to the words written opposite the food: Every day, 2-3 times a week, once a week, 2-3 times a month, once a month, or never.
Autism Meal Behavior Brief Scale
The scale aims to evaluate the nutritional problems observed in individuals with autism and intellectual disability. It consists of three subscales and 18 items: food refusal, limitation in food variety, and behavioral characteristics related to autism. Food refusal (5-25 points) subscale consists of 5 items, food diversity restriction subscale (8-40 points) consists of 8 items and autism-related behavioral characteristics subscale (5-25 points) consists of 5 items. The scale is in a five-point Likert type and the 3rd, 9th, 10th and 15th items are scored in reverse. A high total score from the scale indicates the severity of nutritional problems, it means negative.
Nutrition Knowledge Level Scales
It is a scale that measures the level of nutrition knowledge. It consists of two parts. first part; It contains 20 questions containing basic nutrition and nutrition-health information. The second part is the part where food preference is questioned, which consists of 12 questions. The first part that questions the basic knowledge level is between 0-80 points, and the higher the score, the higher the level of knowledge. The second section questioning food preference is between 0-48 points, and the higher the score, the better the food choice.

Secondary Outcome Measures

Body mass index calculation
After determining the height and weight, it will be calculated with the kilogram/square meter formula.

Full Information

First Posted
December 9, 2022
Last Updated
April 19, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05838352
Brief Title
Multidisciplinary Telerehabilitation Practices in Autism
Official Title
The Effect of Physiotherapy and Nutrition Services Provided by Telerehabilitation Method on the Physical, Nutrition and Psychological Conditions of Children With Autism and Their Families
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Our study, which investigators named the Effect of Physiotherapy and Nutrition Services Provided with Telerehabilitation Methods on the Physical, Nutrition and Psychological Conditions of Children with Autism and their Families, was aimed to evaluate the effects of physiotherapy and nutrition education to be given to families. Children with autism spectrum disorder There will be questionnaires that investigators will ask participants to answer about your personal information and some questions about your life. Via a smart phone video conference to caring parents of children with autism; In this project, a physiotherapist and a physiotherapy senior physiotherapy trainee will send 1 session of online simultaneous exercise training to the parents, followed by an exercise video containing the exercises, brochures, and parents will be asked to do the exercises 3 days a week. The subjects will be asked to keep an exercise diary and the status of the diaries will be followed up once a week. In addition, the concepts of physical activity and recreational activity will be explained, and counseling and training will be given to parents who will guide their children with autism. To foster parents of children with autism via smart phone video conference; Within the scope of basic nutrition and nutrition-health information, three different nutrition training will be given at 15-day intervals, accompanied by a dietitian and a senior student of Nutrition and Dietetics. Your children's waist, hip, and height measurements will be measured with a tape measure, and their body weight will be measured with a weighing machine. The study will take 2 months.
Detailed Description
There are some studies in the literature on the investigation of physical activity and nutrition in the diagnosis of Autism Spectrum Disorder (ASD). This project will be the first multidisciplinary and most comprehensive study involving a physiotherapist and dietitian in Turkey on children with ASD and their parents. It will contribute to the literature by evaluating primary school-age (6-11) children with autism from a multidisciplinary perspective in terms of physiotherapy and nutrition, as well as being a randomized controlled study that provides physical activity and nutrition education to the family. In addition, the quality of life, activity participation and recreational activity level of children with autism will be measured. In line with these measurements, parents will be told about recreational activities to guide their children with ASD and counseling will be given to their children for their implementation. For parents; quality of life, functional status, and stress levels will be evaluated. As a result of these evaluations, breathing, resistance, and posture exercises and walking training will be given and the effectiveness of these training will be evaluated. In this training, the current approach, telerehabilitation, will be used. Telerehabilitation is a cost-effective, easy-to-access alternative to traditional treatment options. The stress level of the parents will be measured before and after the physiotherapy and nutrition training, investigators provide to the parents. In the literature, attention is drawn to nutritional problems such as food refusal, food selectivity, and obesity in children with ASD. Adequate and balanced nutrition is very important for the mental and physical health, growth, and development of children. For this purpose, it should be aimed to raise awareness of both parents and children about healthy nutrition. In the study, the nutritional status, frequency of food consumption, and food selectivity/rejection of children with ASD will be determined. Anthropometric measurements of children such as height, weight, upper middle arm circumference (UOKC), and body mass index (BMI) will be taken and evaluated according to their age and gender. The nutritional knowledge level of the parents at the beginning will be measured, and the knowledge level at the end of the study will be determined by giving nutrition education during the study. The training to be given synchronously will be given using technological devices, and the training will be transmitted as videos later to ensure that they are easily accessible for the parents. Again, in order to make the education more understandable and attractive, brochures on physiotherapy and nutrition will be delivered to the parents before the education.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physiotherapy and Rehabilitation, Nutrition, Autism Spectrum Disorder, Telerehabilitation
Keywords
Physiotherapy and Rehabilitation, Nutrition, Autism Spectrum Disorder, Telerehabilitation, Multidisciplinary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation Group (TRG)
Arm Type
Experimental
Arm Description
The group given physical activity and nutrition counseling for 2 months through telerehabilitation.
Arm Title
Conventional Rehabilitation Group (CRG)
Arm Type
Active Comparator
Arm Description
The group who received conventional treatment and had no intervention, only pretest measurements
Intervention Type
Other
Intervention Name(s)
telerehabilitation exercise
Other Intervention Name(s)
Exercise program, Physical Activity Education, Nutrition Education
Intervention Description
The telerehabilitation program is as follows; Respiratory exercises: Chest, diaphragmatic breathing and lower basal breathing exercises will be performed with 10 repetitions.Resistance exercises: Strengthening exercises will be performed on the major muscle groups of the upper and lower extremities, using medium-hardness resistance exercise band. During the exercises, the patient's fatigue and dyspnea levels will be questioned using the Borg scale, and breaks will be given when necessary. Exercises 1st-3rd weeks with 10 repetitions; 15 repetitions in weeks 4-6; In the 7th and 8th weeks, it will be done as 2 sets of 10 repetitions.Posture exercises: Basic posture exercises will be explained. Tabletop movements will be taught in clear, various positions that concern the spine, scapula and pelvis.Gait training: In line with the data obtained from the 6-minute walking test, gait training will be given on flat ground at 60% workload (land-based walking).
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
The surveys in the outcome measures section will be applied once as a pre-test. Children in both groups will receive conventional institutional rehabilitation in the rehabilitation center. Children in the conventional rehabilitation group, which is the control group, will only be included in the supervised program. This group will not receive a telerehabilitation program.
Primary Outcome Measure Information:
Title
Functional Independence Measure for Children (WeeFIM)
Description
Functional Independence measure for children (WeeFIM) is an adaptation of the Functional Independence Measure (FIM) developed for adults. It is a useful, short and comprehensive measurement tool that detects the developmental, educational and social functional limitations of children with Cerebral Palsy and other developmental disorders. WeeFIM consists of 18 items in 6 areas The scores that can be obtained from the scale are between 18 and 126. The higher the score, the higher the child's independence. A higher score indicates positive improvement.
Time Frame
Change from baseline WeeFIM score at 6 weeks
Title
Quality of Life Questionnaire in Autism
Description
It has been divided into two subsections (A and B). Part A contains 28 questions that measure how parents perceive their quality of life. Part B contains 20 questions that assess parents' perceptions of how much of a problem their child's autism-specific difficulties are for them. In the five-point Likert-type assessment measure, in which they evaluate how problematic these situations are for the parents, five are scored as 'It was not a problem for me at all', while one is scored as 'It was a lot of trouble for me'. The score that can be obtained from the scale is between 48-240. A high score indicates an improved quality of life.
Time Frame
Change from baseline Quality of Life Questionnaire in Autism score at 6 weeks
Title
Cornell musculoskeletal discomfort questionnaire
Description
The questionnaire surveyed the frequency and severity of pain or discomfort in 11 different body regions (neck, shoulder, back, upper arm, wrist, forearm, wrist, hip, upper leg, knee, and lower leg) during the work period in the last week. assessing its impact on performance. For each body region, the weighted score of that body region is calculated by multiplying the ratings marked from the areas of frequency, severity, and effect on work performance. Scores for each region range from 0 to 90. A high score indicates that the region has a pain and disability.
Time Frame
Change from baseline Cornell musculoskeletal discomfort questionnaire score at 6 weeks
Title
Beck Depression Inventory
Description
It is used to objectively determine the level of depression exhibited by individuals. Beck Depression Inventory includes 21 categories of depressive symptoms. Each of these categories consists of 4 items for self-assessment and is graded between 0 and 3 points.
Time Frame
Change from baseline Beck Depression Inventory score at 6 weeks
Title
6 minutes walking test
Description
The 6-minute walk test measures the distance the patient can walk quickly on a flat, hard surface in a period of 6 minutes. It evaluates the integrated responses of all systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. The vital signs of the participants were taken before and after the test. The 6 minute walk test (6MWT) built in a 30 m-long straight corridor. The patient was asked to walk as much as they could, and the distance walked was recorded in meters.
Time Frame
Change from baseline 6 minute walking distance at 6 weeks
Title
Evaluation of Participation in Activities
Description
In the study, with the form the investigators created to evaluate the participation of children with special needs in leisure activities, the demographic characteristics of the children, their educational status, the economic status of their families, the type and reason for their disability were asked to the families, which activities they wanted to do and what they did, the situations that prevented them from participating in the activities and the assistive tools they used were asked to the children. evaluated.
Time Frame
Change from baseline Evaluation of Participation in Activities at 6 weeks
Title
Evaluation of Family Role in Activity Participation
Description
A form was created that included the questions of who decides the activities that the children will do, whether the families control them during the activity, whether the children are willing to participate in the activity and whether they can express the activity they participate in, to what extent the families approve of their children's ideas and to what extent they encourage their children to participate in the activities. the role was evaluated.
Time Frame
Change from baseline Evaluation of Family Role in Activity Participation at 6 weeks
Title
Childhood Autism Rating Scale
Description
The Childhood Autism Rating Scale can be applied to children of all age groups starting from the preschool period. It is a 15-item scale that evaluates behaviors in 14 areas that are generally affected by serious problems in autism and a general impression category of autism. Each question has a rating of 1-4. It means mild autism between 15 and 29 points, moderate autism between 30 and 36 points and severe autism between 37 and 60 points.
Time Frame
Change from baseline Childhood Autism Rating Scale score at 6 weeks
Title
Food Consumption Frequency Questionnaire
Description
In order to determine the food consumption status of children with autism, it was applied to parents of children with an autism spectrum disorder. The questionnaire separates 5 food groups and includes the foods belonging to each food group under these groups. The frequency of food consumption was determined by the answer given to the words written opposite the food: Every day, 2-3 times a week, once a week, 2-3 times a month, once a month, or never.
Time Frame
Change from baseline Food Consumption Frequency Questionnaire score at 6 weeks
Title
Autism Meal Behavior Brief Scale
Description
The scale aims to evaluate the nutritional problems observed in individuals with autism and intellectual disability. It consists of three subscales and 18 items: food refusal, limitation in food variety, and behavioral characteristics related to autism. Food refusal (5-25 points) subscale consists of 5 items, food diversity restriction subscale (8-40 points) consists of 8 items and autism-related behavioral characteristics subscale (5-25 points) consists of 5 items. The scale is in a five-point Likert type and the 3rd, 9th, 10th and 15th items are scored in reverse. A high total score from the scale indicates the severity of nutritional problems, it means negative.
Time Frame
Change from baseline Autism Meal Behavior Brief Scale score at 6 weeks
Title
Nutrition Knowledge Level Scales
Description
It is a scale that measures the level of nutrition knowledge. It consists of two parts. first part; It contains 20 questions containing basic nutrition and nutrition-health information. The second part is the part where food preference is questioned, which consists of 12 questions. The first part that questions the basic knowledge level is between 0-80 points, and the higher the score, the higher the level of knowledge. The second section questioning food preference is between 0-48 points, and the higher the score, the better the food choice.
Time Frame
Change from baseline Nutrition Knowledge Level Scales score at 6 weeks
Secondary Outcome Measure Information:
Title
Body mass index calculation
Description
After determining the height and weight, it will be calculated with the kilogram/square meter formula.
Time Frame
Change from baseline Body mass index at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Volunteering to participate in the study 6-11 years old child Have an approved medical diagnosis for Asperger's syndrome, autism, or a specific developmental disorder (DSM 5), by the standards set in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition Children with mild to moderate autism according to the childhood autism rating scale Not having received physical activity and nutrition counseling before Children with normal orally fed and functioning gastrointestinal tract Exclusion Criteria: Having any serious condition (such as orthopedic or any acute) for which it is contraindicated to the viewer of recreational entertainment programs Recent (less than 4 weeks) children on any psychotropic medication Those who have high-intensity activity according to the International Physical Activity Questionnaire (IPAQ) Children with chewing and swallowing difficulties You can enter as a child suitable for children. Children with diagnosed nutritional problems (absorption disorder, metabolic structure) have Gastroenterol patients suitable for medical intervention or bowel segments, Leukemia or other cancers, Hypothyroidism or other chronic conditions that can grow and turn into energy Acute myocarditis, active endocarditis, control eg missed heart probe, tachyarrhythmia, bradyarrhythmia, hypertrophic cardiomyopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Pehlivan, assoc. prof.
Phone
+902163463636
Email
esra.pehlivan@sbu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Amine Ataç, MSc, Pt
Phone
+902124090200
Email
amineatac@gmail.com
Facility Information:
Facility Name
Saglik Bilimleri Universitesi
City
Istanbul
State/Province
Uskudar
ZIP/Postal Code
34674
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esra Pehlivan
Phone
+902163463636
Email
esra.pehlivan@sbu.edu.tr
First Name & Middle Initial & Last Name & Degree
Amine Ataç
Phone
+902124090200
Email
amineatac@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Multidisciplinary Telerehabilitation Practices in Autism

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