Treadmill Training With and Without Weighted Ankle Cuffs on Gait Parameters
Key facts
- Who runs it
- Riphah International University
- Where
- Pakistan1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 46 people enrolled
- Started
- 26 Oct 2023
- Ended
- 28 Dec 2023
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Treadmill training with weighted ankle cuffs
- Treadmill training
- Record updated
- 30 January 2024
Who can take part
- Age
- 5 years to 10 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Treadmill training with weighted ankle cuffsTreatment being tested
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 trainingExisting treatment, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Treadmill Training With and Without Weighted Ankle Cuffs on Gait Parameters in Children With Down's Syndrome
- Record updated
- 30 January 2024