Treadmill Training With and Without Weighted Ankle Cuffs on Gait Parameters

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

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.

Study Overview

• Status: Completed
• Conditions: Down's Syndrome
• Intervention / Treatment: Other: Treadmill training with weighted ankle cuffs; Other: Treadmill training

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 540000
      • Riphah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treadmill training with weighted ankle cuffs; 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; 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.
Active Comparator: 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.	Other: Treadmill training; Treadmill training only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Asma Iqbal, MS*, Riphah International University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Berg Balance scale, Down syndrome, Gait parameter, Posture
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: REC/RCR&AHS/23/0749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No