Treadmill Training With and Without Weighted Ankle Cuffs on Gait Parameters
Condition: Down's Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

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.
    

Intervention name(s): Treadmill training with weighted ankle cuffs; Treadmill training
Intervention type(s): Other; Other
Intervention description(s): 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 only
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Control Trial
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Berg Balance scale, Down syndrome, Gait parameter, Posture