- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07575165
Mindful Movement And GAME BASED Training In Developmental Delay (MINDGAME)
Comparative Effects Of Mindful Movement And Game Based Training On Motor Skills, Balance And Gait In Children With Developmental Delay
Developmental delay in children is characterized by delayed acquisition of cognitive, motor, language, and social skills and is commonly associated with conditions such as cerebral palsy, autism spectrum disorder, and genetic disorders. Children with developmental delay frequently experience impairments in motor skills, balance, and gait, which negatively a ffect their functional independence and social participation. Addressing these motor deficits is essential to enhance their quality of life.
Mindful movement and game-based training are two therapeutic approaches that have shown potential in improving motor performance in this population. Mindful movement emphasizes slow, controlled movements, body awareness, emotional regulation, imaginative play, and biomechanical warm-up exercises to enhance motor control. In contrast, game-based training employs engaging and interactive activities to improve motor coordination, balance, strength, and social interaction.
This randomized clinical trial aims to compare the effects of mindful movement and game-based training in children with developmental delay. The study will be conducted at Acme Hospital over a 10-month period and will include 36 children aged 9-11 years selected through non-probability convenient sampling. Participants will be assigned into two groups: Group A will receive mindful movement therapy, and Group B will undergo game-based training. Outcomes will be assessed using validated tools, including the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Pediatric Berg Balance Scale (PBS), Functional Reach Test (FRT), Observational Gait Scale (OGS), and Edinburgh Visual Gait Score (EVGS), to evaluate motor skills, balance, gait, and overall motor proficiency.
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Imran Amjad, PhD
- 전화번호: 03324390125
- 이메일: imran.amjad@riphah.edu.pk
연구 연락처 백업
- 이름: Khadija Liaquat, MS-NMPT
- 전화번호: 03334956854
- 이메일: khadijaliaquat90@gmail.com
연구 장소
-
-
Punjab Province
-
Lahore, Punjab Province, 파키스탄, 54000
- Riphah Rehabilitation Center, Riphah International University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children age 9-11 years
- Both male and female
- Children diagnosed with developmental delay
- Mini mental state examination >24
- Participants who are able to understand and follow the instruction
- Bruininks-Oseretsky Test of Motor Proficiency (BOT-2): < 40
- Pediatric Berg Balance Scale (PBS) score of less than 45
- Functional Reach Test (FRT): 6-7 inches
- Observational Gait Scale (OGS): 0-3, >10
- Edinburgh Visual Gait Score (EVGS): < 37
Exclusion Criteria:
- Any cognitive impairment that limits understanding of instructions
- Uncontrolled seizures or medical conditions that contraindicate therapy
- Participation in other structured physiotherapy programs targeting motor skills, gait and balance
- Children with severe visual or hearing impairments affecting the ability to follow intervention activities .
- Children with recent lower-limb orthopedic injuries, fractures, or surgeries within the previous 6 months.
- Children with diagnosed genetic neuromuscular disorders associated with progressive motor deterioration (e.g., muscular dystrophy).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm A: Mindful Movement Intervention
Participants in Arm A will receive a mindful movement program aimed at improving motor skills, balance, coordination, and emotional regulation.
|
The intervention includes biomechanical warm-up exercises, imaginative play, animal-based movements, and reflective activities to enhance body awareness, posture, focus, and relaxation. Emphasis is placed on slow, controlled movements to promote mindfulness and overall physical and mental well-being. Each session will last 30-45 minutes, conducted two times per week, total 12 weeks. Components include: Biomechanical warm-ups: Gentle joint mobility exercises such as shoulder circles and slow marching (5-10 minutes). Imaginative play: Creative movement activities (e.g., tree pose with storytelling, emotion walks, breathing with hand tracing) , Animal walks(bear walk, cat walk) to improve strength, coordination, and balance (approximately 30 minutes). Reflection and cool down: Mirror movements and "balloon hands" using slow, controlled hand movements to promote relaxation and motor control.(5 minutes) |
|
실험적: Arm B: Game-Based Training Intervention
Participants in Arm B will receive a game-based training program designed to improve motor skills, balance, gait, strength, and overall fitness through engaging and age-appropriate games .
|
The intervention emphasizes active participation, enjoyment, and cognitive engagement. Each session will last 30-45 minutes, conducted two times per week, total 12 weeks. Components include: Warm-up: Walking activities to increase body temperature (5-10 minutes). Main practice: Game-based aerobic, strength, balance, and coordination activities such as The Sea, The Astronauts, Give Your Ball, and The Game of Colors (approximately 30 minutes). Cool-down: Deep breathing exercises to promote relaxation and reduce heart rate (5 minutes). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Motor Skill Performance
기간: Baseline and 12 weeks
|
Tool: Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) Outcome: Change in BOT-2 total motor composite score The BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency, Second Edition) scoring converts raw scores into precise motor proficiency metrics for ages 4-21, using sex-specific norms.
|
Baseline and 12 weeks
|
|
Balance Ability
기간: Baseline and 12 weeks
|
Tool: Pediatric Berg Balance Scale (PBS) Outcome: Change in PBS score
|
Baseline and 12 weeks
|
|
Gait Quality
기간: Baseline and 12 weeks
|
Tools: Observational Gait Scale (OGS); The Observational Gait Scale (OGS) is a validated tool used to assess gait quality, particularly in children with cerebral palsy, by scoring key kinematic parameters from video or direct observation.
It rates 8 specific gait components in the sagittal plane-including knee position, foot contact, and heel rise-resulting in a maximum score of 22 per limb.
Lower scores indicate greater impairments
|
Baseline and 12 weeks
|
|
Edinburgh Gait Scale
기간: Baseline and 12 weeks
|
The Edinburgh Visual Gait Score (EVGS) is a comprehensive, video-based observational tool used to assess gait abnormalities, primarily in children with cerebral palsy (CP).
It evaluates 17 parameters per limb across sagittal and coronal planes-focusing on the foot, knee, hip, pelvis, and trunk-using a 3-point ordinal scale (0=normal, 1=mild/moderate, 2=severe).
|
Baseline and 12 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Nimra Javed, Riphah International University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RCR & AHS/25/0709/Nimra Javed
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .