Effects of Body Weight Supported Treadmill Training on Motor Development in Patients With Dyskinetic Cerebral Palsy

Official title

Effects of Body Weight Supported Treadmill Training on Motor Development in Patients Withh Dyskinetic Cerebral Palsy

Overview

This randomized controlled trial will evaluate motor development outcomes in children aged 5-12 years with dyskinetic cerebral palsy. The Primary Outcome measures will be Gross motor development, gait, trunk control, balance, and coordination, and will be assessed using the Shoaib Sensorimotor Development Tool (SMDT), Gross Motor Function Measure-88 (GMFM-88), Jacks' observational Gait Analysis scale, Trunk Impairment Scale (TIS), Time Up and Go Test, and Heel-to-Shin test. The fine motor development as a secondary outcome measure will be assessed using the Box and Block Test (BBT). Before allocating participants within the study, informed consent will be obtained to ensure rigorous adherence to the Principles of Ethical Research as outlined in the Helsinki Declaration for Ethical Research. Baseline readings will be recorded using the selected tools against the pre-defined outcome measures. Randomization will be done through an online tool, and the Participants will be divided into two intervention arms. The control group will receive conventional Bobath therapy, and the experimental group will undergo body weight-supported treadmill training (BWSTT), with both interventions administered over a period of 4 weeks, 5 days a week. Each session will be structured as follows: 5 minutes of warm-up exercises to prepare the body, followed by a 30-minute core treatment session focused on therapeutic interventions, concluding with 5 minutes of cooldown exercises to promote recovery and relaxation. This sequence ensures a balanced approach while maintaining the total session duration of 40 minutes, 5 days a week for 4 weeks. Statistical analysis of the results will be conducted using SPSS software to determine the significance of the findings. The Shapiro-Wilk test will be employed to determine the normality of the data. If the data distribution is normal, an independent t-test will be employed for between-group comparison; otherwise, non-parametric alternatives will be applied. Within group analysis, a paired t-test will be applied to evaluate differences and the results will be reported.

Detailed description

The interventions to both groups will be applied for 40 minutes, 5 days a week, for 4 weeks. 5 minutes of warm-up and cool-down exercises will be administered to both groups before and after the administration of interventions. Subsequently, participants will receive 30 minutes of treatment according to the pre-designed protocol.

* Group A, or the experimental group, will receive BWSTT with 40% weight offloading and a treadmill speed of 0.4 miles per hour (mph) at the start of the treatment. * Weight offloading will be progressively decreased by 10% each week, leading to 30% offloading in the 2nd week, with the treadmill speed adjusting to 0.8 mph * 20% offloading in the 3rd week, with speed increasing to 1.2 mph; and 10% offloading during the 4th week of the intervention at a speed of 1.6 mph, for 30 minutes a day, five days a week for four weeks.

40-minute BWSTT treatment sessions will have 8 minutes of exercise intervals followed by 2-minute rest intervals (16).

In contrast, GROUP-B or the control group will be given Bobath therapy.

* This will include dynamic balance training on a balance board for 6 minutes, followed by a 2-minute rest. * functional reaching, and ball-throwing exercises for 6 minutes, followed by a 2-minute rest period. * Supine pelvic bridging exercises for 6 minutes, followed by a 2-minute rest interval. * weight-bearing exercises in sitting, standing, kneeling, and crawling positions to facilitate equal body weight transfers without disturbing postural control for another six minutes, followed by two minutes of rest. * Obstacle negotiation (cones, steps) with focus on: Heel-strike initiation, Stance-phase knee control, and Push-off symmetry for six minutes.

Interventions

• Other BODY WEIGHT SUPPORTED TREADMILL TRAINING
  The experimental group, will receive BWSTT with 40% weight offloading and a treadmill speed of 0.4 miles per hour (mph) at the start of the treatment. Weight offloading will be progressively decreased by 10% each week, leading to 30% offloading in the 2nd week, with the treadmill speed adjusting to 0.8 mph, 20% offloading in the 3rd week, with speed increasing to 1.2 mph; and 10% offloading during the 4th week of the intervention at a speed of 1.6 mph, for 30 minutes a day, five days a week for
• Other BOBATH THERAPY
  The control group, will receive Bobath Therapy. The protocol will include dynamic balance training on a balance board for 6 minutes, followed by a 2-minute rest. Functional reaching and ball-throwing exercises for 6 minutes, followed by a 2-minute rest period. Supine pelvic bridging exercises for 6 minutes, followed by 2-minute rest intervals. weight-bearing exercises in sitting, standing, kneeling, and crawling positions to facilitate equal body weight transfers without disturbing postural cont

Primary outcome measures

• Gross motor Development [Time frame: 4 weeks]
• Gross motor Development [Time frame: 4 weeks]
• Gait analysis [Time frame: 4 week]
• trunk control [Time frame: 4 weeks]
• Dynamic Balance and functional mobility [Time frame: 4 weeks]
• motor coordination assessment [Time frame: 4 weeks]

Secondary outcome measures (1)

• Fine Motor Development [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

\- This study will include DCP Patients aged 5-12 years without any gender preference, falling at GMFCS levels I-II. The included participants must be capable of following instructions and must not have any known surgical or medical history.

Exclusion criteria

• DCP patients having cardiac complications, Past surgical history, Mental retardation, visual and cognitive deficits, under another gait training protocol, Congenital musculoskeletal defects, dislocations of the hip, significant hip and knee contractures, Behavioral disorders, or a history of Recent botulinum toxin injections, or uncontrolled epilepsy will be excluded from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• University of Biological and Applied Sciences — Lahore

Identifiers

NCT: NCT07263542 · UBS24LMSPT011

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗