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CompletedNCT06522451Updated Oct 29, 2024

Effects of Conventional Physical Therapy With and Without Cuevas Medek Exercises in Developmental Delay

An interventional study of conventional physical therapy and Conventional physical therapy along with cuevas medek exercises in Motor Delay, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 1 Year to 4 Years. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
1 Year to 4 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Motor Delay

Keywords

  • Cuevas Medek exercises
  • developmental delay
03

In context

Psychomotor Disorders

24 studies on the registry are indexed under Psychomotor Disorders; 7 are open to participants now.

This study's enrollment of 24 is below the median of 49 across 17 interventional studies indexed under Psychomotor Disorders.

Browse Psychomotor Disorders studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,176 studies on the registry; 637 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 4 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Conventional Physical Therapy

    This group receives conventional physical therapy

    Other: conventional physical therapy

  • Experimental
    Conventional physical therapy with cuevas medek exercises

    This group receives conventional physical therapy along with cuevas medek exercises

    Other: Conventional physical therapy along with cuevas medek exercises

Interventions

  • Otherconventional physical therapy

    Only conventional physical therapy (CPT) will be administered to this group. 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.

  • OtherConventional physical therapy along with cuevas medek exercises

    In addition to regular physical therapy, this group will get Cuevas Medak exercises including 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 the baseline, the functional state of both groups will be evaluated.

06

What researchers measure

Primary outcomes

  1. Bayley Scales of Infant and toddler Development IV

    The Bayley scales of infants and toddlers IV (BSID-4) is an individually administered instrument that evaluates the developmental functioning of infants and young children between the ages of one and forty-two months. There are two ways to administer the BSID-4: the Social-Emotional and Adaptive Behavior scales, which is a questionnaire that parents or caregivers complete, and the Cognitive, Language, and Motor scales, which are administered by a qualified professional and scored through observation and direct interaction with the child. To obtain qualitative information about motor skills (e.g., attends to the examiner on camera, shifts attention when name is called, babbles, reaches and groups objects), the BSID-4 contains 56 items in the gross motor domain.

    Time frame: 12 weeks

  2. Peabody Developmental Motor Scale

    Peabody Developmental Motor Scales (PDMS-2) is composed of six subtests that measure interrelated abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through five years of age. This subtest measures aspects of a child's ability to automatically react to environmental events. Because reflexes typically become integrated by the time a child is 12 months old, this subtest is given only to children ages 2 weeks through 11 months. It measures a child's ability to sustain control of the body within its center of gravity and retain equilibrium

    Time frame: 12 weeks

07

Study locations

1 site
  • Imran Amjad
    Lahore, Punjab Province 54000, Pakistan
08

References and documents

Publications

  • 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. PubMed 28407535 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06522451
Responsible party
Sponsor
First posted
Jul 26, 2024
Start date
Jun 28, 2024
Primary completion
Aug 20, 2024
Completion
Aug 25, 2024
Last update
Oct 29, 2024

Study contacts

Misbah Bashir, MS
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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