Clinical trial NCT06176755: Treadmill Training With and Without Weighted Ankle Cuffs on Gait Parameters
Official title: Effects of Treadmill Training With and Without Weighted Ankle Cuffs on Gait Parameters in Children With Down's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down's Syndrome
Keywords: Berg Balance scale, Down syndrome, Gait parameter, Posture
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Control Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Berg balance scale for functional balance
timeFrame: 4weeks
measure: Gait Abnormality Rating Scale (GARS)
timeFrame: 4weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah international university
state: Punjab
Study officials:
affiliation: Riphah International University
name: Asma Iqbal, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: VanSwearingen JM, Paschal KA, Bonino P, Yang JF. The modified Gait Abnormality Rating Scale for recognizing the risk of recurrent falls in community-dwelling elderly adults. Phys Ther. 1996 Sep;76(9):994-1002. doi: 10.1093/ptj/76.9.994.