Clinical trial NCT06522451: Effects of Conventional Physical Therapy With and Without Cuevas Medek Exercises in Developmental Delay
Official title: Effects of Conventional Physical Therapy With and Without Cuevas Medek Exercises on Gross Motor Function in Children With Motor Developmental Delay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Delay
Keywords: Cuevas Medek exercises
developmental delay
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be Randomized control trial in which non probability convenient sampling will be used. Two groups of age 12-42 months will be formed in which participants will be randomly divided. Group A will only receive conventional physical therapy and group B will receive conventional physical therapy with cuevas medek exercises
Primary purpose: TREATMENT

Brief summary: There are several etiologies for developmental delay (DD). One of the main causes of developmental delay is cerebral palsy (CP), which has a variety of clinical characteristics brought on by damage to the developing brain. Children with developmental delays frequently have difficulties with feeling, perception, cognition, communication, musculoskeletal disorders, and movement and posture. A child's developmental delay could be avoided and motor milestones could be reached with the help of a CME-based intervention. In order to lessen or prevent developmental motor delay, CME-based intervention may be taken into consideration as a research issue and as an option for either intensive or conventional therapy.

A randomized control trial will be used for this. The Sehat Medical Complex in Lahore's physiotherapy department would be the source of the data collection. This study includes children of any gender between the ages of 12 and 42 months. Babies with motor developmental delays are diagnosed and their treatment plans are developed using the Bayley Scales of Infants and Toddlers IV (BSID-4). Conventional physical treatment, including dynamic/static stretches, functional exercises, passive mobilizations, balance modulation, and gait training, was administered to group A. At baseline, the functional state of both groups will be evaluated. Treatment sessions will run for a total of 12 weeks, five days a week, for 45 minutes each. They will consist of four to six repeated exercises, six times on average, and will continue to use BSID-4 after the study is finished. Group B includes Cuevas Medak exercises like transition and head and trunk control (by stabilizing limb) and sitting-to-standing transition are recommended. For a duration of 12 weeks, five days a week, and 45 minutes, each session will be held. At baseline, the functional state of both groups will be evaluated. then once the sessions are over, more data will be gathered using BSID-4. This research will help determine the efficacy of CME therapy in addition to traditional physical therapy.

Detailed description: Group A: Control Group: The only form of physical therapy (CPT) given to this group will be conventional CPT. These regular workouts will include dynamic and static stretching, walking-specific functional exercises, passive mobilizations for pain-free mobility, balance modulation, and gait training. At baseline, the functional state of both groups will be evaluated. Treatment sessions will run for a total of 12 weeks, five days a week, for 45 minutes each. They will consist of four to six repeated exercises, six times on average, and use BSID-4 once the trial is over.

Group B: Experimental Group: In addition to regular physical therapy, this group will also get Cuevas Medak exercises, such as head and trunk control (by stabilizing limb) and standing to sitting transition. For a duration of 12 weeks, five days a week, and 45 minutes, each session will be held. At baseline, the functional state of both groups will be evaluated. then once the sessions are over, more data will be gathered using BSID-4.

Eligibility criteria: Inclusion Criteria:

* Children with motor developmental delay will only be included, and it will be ruled out by using Portage's Guide.
* Age between 12 and 42 months.
* Both genders

Exclusion Criteria:

* Individuals who suffer from particular neurological impairments, such as hydrocephalus, or who have related conditions.
* Patients with systemic disorders, infectious diseases, or vision impairment will not be accepted.
* Spinal surgery history

Primary outcomes:
measure: Bayley Scales of Infant and toddler Development IV
timeFrame: 12 weeks
measure: Peabody Developmental Motor Scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Imran Amjad
state: Punjab
Study officials:
affiliation: Riphah International University
name: Misbah Bashir, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Keer I, Colla S, Van Leeuwen K, Vlaskamp C, Ceulemans E, Hoppenbrouwers K, Desoete A, Maes B. Exploring parental behavior and child interactive engagement: A study on children with a significant cognitive and motor developmental delay. Res Dev Disabil. 2017 May;64:131-142. doi: 10.1016/j.ridd.2017.04.002. Epub 2017 Apr 10.