Treadmill Training With and Without Weighted Ankle Cuffs on Gait Parameters

NCT06176755 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0749
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Down's Syndrome

Keywords

Berg Balance scale, Down syndrome, Gait parameter, Posture

Outcome Measures

Primary Outcomes (2)

• Berg balance scale for functional balance

  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.

  4weeks

• Gait Abnormality Rating Scale (GARS)

  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

  4weeks

Study Arms (2)

Treadmill training with weighted ankle cuffs

EXPERIMENTAL

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

Other: Treadmill training with weighted ankle cuffs

Treadmill training

ACTIVE COMPARATOR

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.

Other: Treadmill training

Interventions

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 with weighted ankle cuffs

Treadmill training OTHER

Treadmill training only

Treadmill training

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 540000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 8790277 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Asma Iqbal, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: December 20, 2023
• Study Start: October 26, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 28, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)