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Completed

NCT Number: NCT06176755

Treadmill Training With and Without Weighted Ankle Cuffs on Gait Parameters

Down syndrome is a condition in which a person has an extra chromosome. Chromosomes are small "packages" of genes in the body. Down syndrome (DS), also known as trisomy 21, is caused by the presence of all or part of a third copy of chromosome 21. It is named after John Langdon Down, the British physician who described the syndrome for the first time in 1866.Down syndrome remains the most common chromosomal condition diagnosed in the United States.

Current study will be randomized controlled trial. Study will be approved by ethical committee. After that informed consent will be taken and patients will be included in the study based on the inclusion criteria. Sampling technique will be simple random sampling the calculated sample sizes will be 25 in each group. All participants will be divided in two groups. One group will receive treadmill training with Weighted Ankle Cuffs and second group will receive treadmill training only. Conventional therapy will be given to both groups which include isometric, strengthening exercise and trunk exercise. The exercise was given for 10 repetitions/session. Infants will receive the treadmill training protocol about 6 min/day, 4 day/week at a belt speed of 0.18m/sec. After taking informed consent baseline measurement will be taken through gait assessment rating scale and Berg balance scale for balance and Gait parameters respectively. Data will be collected before treatment and after 6 weeks. Treatment session will be performed for 1 hour per day, 4 days a week for total of 6 weeks. The difference in improvement before and after 4th weeks will be noted and compared through SPSS 26.0.

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Key information

Conditions

Down's Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah international university

Lahore, Punjab Province, 540000, Pakistan

About this study

Participants will complete a well-tested Performa. Gait parameters will be collected through these questions. The difference in improvement before and after 6th weeks will be noted and compared. Children receive treatment for 4 days a week for 1/day hour for total of 6 weeks.

Group A: Treadmill training and Ankle cuff.

Treadmill training:

Participants in group A will provided with small, motorized, custom-designed treadmills and trained parents to appropriately administer training in their homes. Parents held their infant upright on the treadmill at the front of the belt. The belt of the treadmill, when turned on, moved the infants' legs backward and elicited forward stepping. Whenever infants did not generate steps, parents repositioned the infant to the front of the belt. Infants will receive the protocol about 4 days a week for 1 hour/day for total of 6 weeks at a belt speed of 0.18m/sec. Besides progressively increasing belt speed and daily training duration, we attached to the infants' ankles a small amount of weight that was proportional to their estimated calf mass, and increased the weight over the course of training. Treadmill training terminated when participants walked three steps independently(18).

Weighted Ankle Cuffs: Choose the weight range. Wrap the weight cuff (0.5 kg) around the ankle, tighten enough to avoid sliding along the leg during exercise. Apply hook and loop closure for secured fit. Do change the weight as per advice given by your consultant.

Group B: Treadmill training only. Participants in group A will provided with small, motorized, custom-designed treadmills and trained parents to appropriately administer training in their homes. Parents held their infant upright on the treadmill at the front of the belt. The belt of the treadmill, when turned on, moved the infants' legs backward and elicited forward stepping. Whenever infants did not generate steps, parents repositioned the infant to the front of the belt. Infants will receive the protocol about 4 days a week for 1 hour/day for total of 6 weeks at a belt speed of 0.18m/sec. Besides progressively increasing belt speed and daily training duration, we attached to the infants' ankles a small amount of weight that was proportional to their estimated calf mass, and increased the weight over the course of training. Treadmill training terminated when participants walked three steps independently.

Children will receive treatment for 4 days a week for 1 hour/day for total of 6 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 5 to 10 years
  • Absence of visual and cognitive problems
  • Level 1,2 or 3 on gross motor function scale
  • Function ambulation for at least 12 months

Exclusion criteria

  • Children submitted to orthopedic surgical procedures or neuromuscular block in the 12 Months prior to the training sessions
  • those with orthopedic deformity with indication for surgery

Treatment and study plan

Treadmill training with weighted ankle cuffs

Other

Group A: Treadmill training and Ankle cuff.

Participants in group A will provided with small, motorized, custom-designed treadmills and trained parents to appropriately administer training in their homes. Parents held their infant upright on the treadmill at the front of the belt. The belt of the treadmill, when turned on, moved the infants' legs backward and elicited forward stepping. Whenever infants did not generate steps, parents repositioned the infant to the front of the belt. Infants will receive the protocol about 4 days a week for 1 hour/day for total of 6 weeks at a belt speed of 0.18m/sec. Besides progressively increasing belt speed and daily training duration, we attached to the infants' ankles a small amount of weight that was proportional to their estimated calf mass, and increased the weight over the course of training. Treadmill training terminated when participants walked three steps independently.

Treadmill training

Other

Treadmill training only

Primary outcomes

  1. Berg balance scale for functional balance

    Time frame: 4weeks

    The Berg balance test - or Berg balance scale (BBS) - is a widely used assessment to determine a person's balance abilities(15). The test contains 14 simple tasks and the entire process takes about 20 minutes to complete. The absolute reliability of the Berg Balance Scale varies across the scale, with minimal detectable change with 95% confidence varying between 2.8/56 and 6.6/56. The absolute reliability is stronger at the high end and weaker towards the middle of the scale.

  2. Gait Abnormality Rating Scale (GARS)

    Time frame: 4weeks

    Gait Abnormality Rating Scale (GARS) is a videotape-based analysis of 16 facets of human gait. It has been evaluated as a screening tool to identify patients at risk for injury from falls. and has been used in remote gait evaluation. A modified version was published in 1996

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Treadmill Training With and Without Weighted Ankle Cuffs on Gait Parameters in Children With Down's Syndrome

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2023
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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