Template:Clinical Trials

Use this template for[edit source]

Studies in 30 subjects which are involved in a trial investigating the effect of an intervention.

Title [edit source]

A STUDY TO CHECK EFFICACY OF TREADMILL INTERVENTION ON IMPROVING WALKING AMONG CHILDREN WITH DOWN SYNDROME”

Keywords [edit source]

TREADMILL, DOWN SYNDROME, WALKING

Word count <11000[edit source]

<11000

Author/s 
[edit source]

Dr. Bhawna


Ethical approval- [edit source]

This research as done by me Ms. Bhawna (MPTpeadiatrics) In Partial Fulfillment of the Requirement for the Degree of MASTER OF PHYSIOTHERAPY [M.P.T] under RGUHS Karnataka.

Abstract[edit source]

The study sought to evaluate the impact of Treadmill interventions to improve walking among Down syndrome subjects.
The study involved 30 patients with DS in the age group of 2-7 years fulfilling the inclusion criteria were selected during convenient sampling methods. Following their inclusion a consent form was obtain from each of them. The results were assessed by 10 Meter Walk Test. Tests were performed before and after completion of study. The study was conducted over period of 9 months.

Result:
The results showed highly significant improvement on walking in children with DS.

Background
[edit source]

Down syndrome (DS) is a genetic condition in which a person has 47 chromosomes instead of the usual 46.Down syndrome occurs when there is an extra copy of chromosome 21.The form of DS is called Trisomy 21.The extra chromosome causes problems with the way the body and brain develop.

Common clinical features in DS are decreased muscle tone, Eyes that have an upward slant, oblique fissures, epicanthic skin folds on the inner corner, and white spots on the iris,Small stature and short neck, Flat nasal bridge Single, deep creases across the center of the palm, Protruding tongue, Large space between large and second toe, A single flexion furrow of the fifth finger.

Objectives
[edit source]

1) To find out the effects of TT on improving walking among children with DS.
2) To study the effect of TT in children with DS for improving the number of steps taken.


Methods[edit source]

Experimental study design (Pre test-Post test)

Study selection or eligibility criteria
[edit source]

• Diagnosis of Down syndrome.
• Age between 2years up to 6years.
• Able to walk minimum 6-10steps with or without support.
• Both genders.

Interventions[edit source]

The research was conducted after taking permission from Ethical Clearance Committee and the administration of the Hospital.After each family agreed to participate in the study by signing a consent form, Children were assessed at the beginning of the study (pretest) with 10 Meter Walk Test.
During the initial phase of treatment, each family was trained on how to hold the child on the treadmill.
Subject were supported on treadmill, holding their under arms by their parents or by therapist hands, so that their feet touched the ground and moved back by the treadmill. Treatment scheduled for 30 minutes, in each session 8minutes walking followed by 2minutes of resting period.


Child feet touched the ground and were moved back by the treadmill with the support provided by their parents or researcher. The hope being that when their foot were too far behind them they were lift it up and put it in front of them. Eventually this would become a practiced pattern that the child had mastered. The treatment session was 30minutes in a day, 5 days in a week for 6 weeks.
Post treatment data with respect to 10 Meter Walk Test were noted at the end of 6weeks.


Measures and variables[edit source]

Outcome measure:
• Steps.
Tools:
• 10 Meter Walk Test38,39.

5.8 STUDY DESIGN
Experimental Study. Pre test-Post test Design.


5.9 SAMPLE DESIGN
Convenient sampling.

5.10 SAMPLE SIZE
Thirty subjects fulfilling the inclusion criteria.

Discussion[edit source]

The objective of the study was to evaluate effectiveness of TT interventions in subjects with DS.
In this study the method of assessment was done through 10 Meter Walk Test. It was used to assess steps and distance cover by subjects in 10 Meter as its validity and reliability has already been established.
The results of the study showed highly significant improvement in steps and distance both with the mean increase of 151.17% in distance and in 72.24% steps.
The improvement of steps and distance in this study concurs with similar founding by Valentin-GudiolMet al47.
In this present study all subjects received Treadmill training for 6weeks. All subjects showed significant improvement in steps (p=.000) and distance (p=.000) and results were highly significant from pre to post interventions.
In the present early intervention study, several infants displayed adequate leg strength and postural control needed to walk and were able to walk well with assistance. Early intervention theory suggests that higher-intensity interventions may produce greater positive outcome.
Hip flexion was present throughout the gait cycle in DS, due to a forward pelvic tilt but with limited excursion. The reason for that may be linked to the anatomical configuration of their pelvic girdle: the so-called "Mongol pelvis" is characterized by a deeper acetabulum and a decrease in the cephalo-caudal diameter and acetabular angle.
In the frontal plane, hip excursion (HAA-ROM index) was lower in DS. This strategy, directly linked to the pelvis movement in the frontal plane (PO-ROM index), appears to produce together with obesity and hypotonia the typical external rotation of the hip during stance.
As for ankle kinematics, DS were characterized by an increased plantar flexion and reduced dorsal flexion throughout the gait cycle with a globally limited ankle range of motion.
The increased hip stiffness in DS we found is consistent with the literature and may represent, together with the anatomical configuration of the pelvic girdle, a compensatory mechanism for muscle weakness. Stiffness values closer to the normal range suggest a more "physiological" walking strategy in DS.
Several factors could have influenced the outcomes. Parenting in the early years of a child's life is hectic and stressful; this situation is magnified when a child in the family has a disability that requires a considerable amount of attention.
It is also possible that too many variables were manipulated in this exploratory attempt to gradually increase the intensity of treadmill training for infants with DS. Manipulating belt speed, and daily duration on the basis of individual infant performance might be too complex. To reduce complexity for parents and researchers, we advise that each condition be manipulated separately.
In considering which procedures to manipulate in the future in an effort to increase intensity, gradually increasing belt speed as an infant increases the frequency of stepping should be the first condition selected. As an infant begins to take more steps on the treadmill, belt speed is associated with more stepping, assuming that the speed is not too fast.
When first starting, the children were not walking consistently for 30 minutes. They would walk for 1-2 minutes, take rest, and try again until they could achieve the full 08 minutes. Speed of treadmill can be adjusted according to the capacity of child foot step on treadmill.


Thayse L.M. Rodenbusch(2013), did a study on Effects of treadmill inclination on the gait of children with Down syndrome and results showed that children with DS presented changes in spatio-temporal variables (reduced cadence and increased cycle time and swing time) and in angular variables (increased hip, knee and ankle angles at initial contact; increased maximum hip flexion and maximum stance dorsi flexion; and reduced plantar flexion at pre-swing)41.
Valentin-Gudiol M, Mattern-Baxter K, Girabent-Farrés M, Bagur-Calafat C, Hadders-Algra M, Angulo-Barroso RM (2013), studied on Delayed motor development may occur in children with Down syndrome, cerebral palsy or children born preterm, which in turn may limit the child's opportunities to explore the environment. Neurophysiologic and early intervention literature suggests that task-specific training facilitates motor development. Treadmill intervention is a good example of loco-motor task-specific training. Treadmill interventions with partial body weight support in children under six years of age at risk of neuro-motor delay: a report of a Cochrane systematic review and concluded that the available evidence indicates that treadmill intervention may accelerate the development of independent walking in children with Down syndrome43.
Mattern-Baxter K et al (2011) did their study on Treadmill interventions with partial body weight support in children under six years of age at risk of neuro-motor delay with 139 subjects and their result suggested that treadmill intervention could lead to earlier onset of independent walking when compared to no treadmill intervention. The available evidence indicates that treadmill intervention may accelerate the development of independent walking in children with Down Syndrome48.


Results
[edit source]

The objective of the study was to evaluate effectiveness of TT interventions in subjects with DS.
In this study the method of assessment was done through 10 Meter Walk Test. It was used to assess steps and distance cover by subjects in 10 Meter as its validity and reliability has already been established.
The results of the study showed highly significant improvement in steps and distance both with the mean increase of 151.17% in distance and in 72.24% steps.
The improvement of steps and distance in this study concurs with similar founding by Valentin-GudiolMet al47.
In this present study all subjects received Treadmill training for 6weeks. All subjects showed significant improvement in steps (p=.000) and distance (p=.000) and results were highly significant from pre to post interventions.
In the present early intervention study, several infants displayed adequate leg strength and postural control needed to walk and were able to walk well with assistance. Early intervention theory suggests that higher-intensity interventions may produce greater positive outcome.
Hip flexion was present throughout the gait cycle in DS, due to a forward pelvic tilt but with limited excursion. The reason for that may be linked to the anatomical configuration of their pelvic girdle: the so-called "Mongol pelvis" is characterized by a deeper acetabulum and a decrease in the cephalo-caudal diameter and acetabular angle.
In the frontal plane, hip excursion (HAA-ROM index) was lower in DS. This strategy, directly linked to the pelvis movement in the frontal plane (PO-ROM index), appears to produce together with obesity and hypotonia the typical external rotation of the hip during stance.
As for ankle kinematics, DS were characterized by an increased plantar flexion and reduced dorsal flexion throughout the gait cycle with a globally limited ankle range of motion.
The increased hip stiffness in DS we found is consistent with the literature and may represent, together with the anatomical configuration of the pelvic girdle, a compensatory mechanism for muscle weakness. Stiffness values closer to the normal range suggest a more "physiological" walking strategy in DS.
Several factors could have influenced the outcomes. Parenting in the early years of a child's life is hectic and stressful; this situation is magnified when a child in the family has a disability that requires a considerable amount of attention.
It is also possible that too many variables were manipulated in this exploratory attempt to gradually increase the intensity of treadmill training for infants with DS. Manipulating belt speed, and daily duration on the basis of individual infant performance might be too complex. To reduce complexity for parents and researchers, we advise that each condition be manipulated separately.
In considering which procedures to manipulate in the future in an effort to increase intensity, gradually increasing belt speed as an infant increases the frequency of stepping should be the first condition selected. As an infant begins to take more steps on the treadmill, belt speed is associated with more stepping, assuming that the speed is not too fast.
When first starting, the children were not walking consistently for 30 minutes. They would walk for 1-2 minutes, take rest, and try again until they could achieve the full 08 minutes. Speed of treadmill can be adjusted according to the capacity of child foot step on treadmill.

Thayse L.M. Rodenbusch(2013), did a study on Effects of treadmill inclination on the gait of children with Down syndrome and results showed that children with DS presented changes in spatio-temporal variables (reduced cadence and increased cycle time and swing time) and in angular variables (increased hip, knee and ankle angles at initial contact; increased maximum hip flexion and maximum stance dorsi flexion; and reduced plantar flexion at pre-swing)41.
Valentin-Gudiol M, Mattern-Baxter K, Girabent-Farrés M, Bagur-Calafat C, Hadders-Algra M, Angulo-Barroso RM (2013), studied on Delayed motor development may occur in children with Down syndrome, cerebral palsy or children born preterm, which in turn may limit the child's opportunities to explore the environment. Neurophysiologic and early intervention literature suggests that task-specific training facilitates motor development. Treadmill intervention is a good example of loco-motor task-specific training. Treadmill interventions with partial body weight support in children under six years of age at risk of neuro-motor delay: a report of a Cochrane systematic review and concluded that the available evidence indicates that treadmill intervention may accelerate the development of independent walking in children with Down syndrome43.
Mattern-Baxter K et al (2011) did their study on Treadmill interventions with partial body weight support in children under six years of age at risk of neuro-motor delay with 139 subjects and their result suggested that treadmill intervention could lead to earlier onset of independent walking when compared to no treadmill intervention. The available evidence indicates that treadmill intervention may accelerate the development of independent walking in children with Down Syndrome48.

Limitations
[edit source]

• Study was done on small sample size (30) further studies are necessary to be done on larger population.
• Duration of study was short (6weeks). Hence long duration intervention is necessary for better outcome measure.
• Unavailability of supporting belt size for every subject so support must be given by hand of parents or therapist.
• Facing difficulty some time in communication with DS children.

Conclusion
[edit source]

Treadmill interventions produced highly significant improvement on walking at the 6th week when compared to baseline values in subjects with DS.
The available evidence indicates that treadmill intervention may accelerate the development of independent walking in children with Down syndrome.
Treadmill training of infants with DS is an excellent supplement to regularly scheduled physical therapy intervention for the purpose of reducing the delay in the onset of walking.
This study provide evidence that, with training and support, parents can use these treadmills in their homes to help their infants with DS learn to walk earlier than they normally would. So this study supported the alternative hypothesis.

Funding and Declerations
[edit source]

NO

Registration number
[edit source]

if appropriate

Author Biography
[edit source]

include a short biography for each author and a link to their profile in Physiopedia

References[edit source]

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