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The Effect of Improvement in Function on Foot Pressure, Balance and Gait in Children With Upper Extremity Affected

Primary Purpose

Upper Extremity Dysfunction, Gait, Unsteady, Juvenile Idiopathic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise protocol
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Extremity Dysfunction focused on measuring Upper Extremity, Physiotherapy, Exercise, Gait, Balance

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • To be in the 10-18 ages group (In order for the devices to comply with the minimum measurement criteria and to be able to cooperate with the study)
  • Being diagnosed with rheumatic diseases at least 6 months ago with only upper extremity affected
  • Unilateral upper extremity involvement

Exclusion Criteria:

  • Having an acute pathology that could affect walking
  • To be diagnosed with orthopedic/neurological pathology that will affect work and cooperation

Sites / Locations

  • Istanbul University-Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

pediatric patients diagnosed with rheumatic diseases.

healthy controls

Arm Description

Exercise group; a combination of stretching, range of motion, and strengthening exercise. The exercise program will take 8 weeks, 3 days per week, and 45 minutes.

The healthy control group will be examined and the outcomes will be compared with the experimental group.

Outcomes

Primary Outcome Measures

Fall risk
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at two different conditions, eyes open comfortable stance and eyes closed comfortable stance. The outcome is the sway variation index (SVI).
Postural Stability
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at one condition, eyes open, and automatic foot placement stance. The outcome is the stability index.
Bilateral Comparison
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at two different conditions, the right leg stance and left leg stance. The outcome is the sway index.
Single limb stance
This outcome will be evaluated with foot pressure analysis. The time between first and second peak forces during walking is the single-limb stance duration.

Secondary Outcome Measures

Arm Swing Amplitude
The difference between the maximum flexion and extension of the shoulder is the arm swing amplitude during walking. The arm swing amplitude will be evaluated 2-dimensionally with the help of the Kinovea video player.
Jebsen-Taylor Hand Function Test
The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). The outcome is the sum of time taken for each sub-test, which is rounded to the nearest second.

Full Information

First Posted
December 5, 2020
Last Updated
April 3, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04671524
Brief Title
The Effect of Improvement in Function on Foot Pressure, Balance and Gait in Children With Upper Extremity Affected
Official Title
Investigation of the Effect of Improvement in Function on Foot Pressure, Balance and Gait in Children With Rheumatic Diseases Whose Upper Extremity Affected
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It has been shown that movements of the upper extremity during walking are associated with lower extremity mobility. For example, when walking at a slow pace, the swing frequency of the arms is 2: 1 compared to the legs, while the limb frequency decreases to 1: 1 as the walking speed increases. That is, in order to walk fast, the lower extremity takes advantage of the acceleration of the upper extremity [1]. It is known that the muscles of the shoulder girdle also support this oscillating movement in the upper extremity during walking. Thus, it is thought that blocking or restricting shoulder girdle and arm movements during walking increases energy expenditure and heart rate, decreases gait stability, and decreases stride length and walking speed [2,3]. However, the possible effects that the upper limb can aid in movement include decreasing vertical displacement of the center of mass, decreasing angular momentum or decreasing ground reaction moment, and increasing walking stability [2-4]. In these studies that restrict arm swing, methods such as crossing the arms on the chest [5], holding the arm in a sling or pocket [6], or fixing the arms to the trunk with a bandage [7] were used. Studies have generally been conducted on healthy individuals or on the biomechanical model, and arm swing during walking has not been investigated in pathologies with only upper extremity involvement (upper extremity fractures, Juvenile Idiopathic Arthritis) without any problems with lower extremity and/or walking. This study is aimed to reveal the effects of decreased upper extremity functionality on walking and balance.
Detailed Description
It has been shown that movements of the upper extremity during walking are associated with lower extremity mobility. For example, when walking at a slow pace, the swing frequency of the arms is 2: 1 compared to the legs, while the limb frequency decreases to 1: 1 as the walking speed increases. That is, in order to walk fast, the lower extremity takes advantage of the acceleration of the upper extremity [1]. It is known that the muscles of the shoulder girdle also support this oscillating movement in the upper extremity during walking. Thus, it is thought that blocking or restricting shoulder girdle and arm movements during walking increases energy expenditure and heart rate, decreases gait stability, and decreases stride length and walking speed [2,3]. However, the possible effects that the upper limb can aid in the movement include decreasing vertical displacement of the center of mass, decreasing angular momentum or decreasing ground reaction moment, and increasing walking stability [2-4]. In these studies that restrict arm swing, methods such as crossing the arms on the chest [5], holding the arm in a sling or pocket [6], or fixing the arms to the trunk with a bandage [7] were used. Studies have generally been conducted on healthy individuals or on the biomechanical model, and arm swing during walking has not been investigated in pathologies with only upper extremity involvement (upper extremity fractures, Juvenile Idiopathic Arthritis) without any problems with lower extremity and/or walking. Studies performed in pathologies where upper extremity mobility and arm swing are affected have shown that the kinetic and kinematic parameters of walking are also affected [8-11]. This change in walking dynamics also changes foot pressure behavior. In a study investigating the effect of arm swing on the affected side on walking in hemiplegic individuals, ground reaction forces on the affected and unaffected sides by foot pressure analysis were examined and it was found that the maximum forces applied during the first contact and toe-off on both sides decreased [12]. In addition, the stance phase duration was higher in hemiplegic patients compared to healthy controls in both lower extremities [12]. This suggests that the affected upper extremity may change the time to transfer weight while walking. In a study investigating the changes in gait parameters in patients with brachial plexus [13] in which ground reaction forces were examined, different gait phase durations and maximum ground reaction force times were found in the affected lower extremity compared to the unaffected side. In a study examining whether the degree of upper extremity functionality has an effect on walking in patients with hemiparetic cerebral palsy; Patients were included in the exercise program aimed at increasing upper extremity function, and as a result, it was found that while upper extremity function increased, patients improved walking parameters and walking distance [14]. Zhou et al. investigated the effects of an active upper extremity exercise program in patients with spinal cord injuries and demonstrated the usefulness of active upper extremity participation in walking [15]. With these results in the literature, the effect of reduced upper extremity function on gait and balance in disease groups (such as rheumatic diseases with only upper extremity involvement, upper extremity fractures) without affecting walking or any neurological/orthopedic diagnosis that may affect walking was not investigated. The aim of this study is to reveal the effects of decreased upper extremity functionality on walking and balance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Dysfunction, Gait, Unsteady, Juvenile Idiopathic Arthritis, Balance
Keywords
Upper Extremity, Physiotherapy, Exercise, Gait, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pediatric patients diagnosed with rheumatic diseases.
Arm Type
Experimental
Arm Description
Exercise group; a combination of stretching, range of motion, and strengthening exercise. The exercise program will take 8 weeks, 3 days per week, and 45 minutes.
Arm Title
healthy controls
Arm Type
No Intervention
Arm Description
The healthy control group will be examined and the outcomes will be compared with the experimental group.
Intervention Type
Other
Intervention Name(s)
Exercise protocol
Intervention Description
a combination of stretching, range of motion, and strengthening exercise.
Primary Outcome Measure Information:
Title
Fall risk
Description
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at two different conditions, eyes open comfortable stance and eyes closed comfortable stance. The outcome is the sway variation index (SVI).
Time Frame
immediately after exercise protocol
Title
Postural Stability
Description
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at one condition, eyes open, and automatic foot placement stance. The outcome is the stability index.
Time Frame
immediately after exercise protocol
Title
Bilateral Comparison
Description
These test results will be evaluated with Biodex Balance device. The test trials are completed on the device at two different conditions, the right leg stance and left leg stance. The outcome is the sway index.
Time Frame
immediately after exercise protocol
Title
Single limb stance
Description
This outcome will be evaluated with foot pressure analysis. The time between first and second peak forces during walking is the single-limb stance duration.
Time Frame
immediately after exercise protocol
Secondary Outcome Measure Information:
Title
Arm Swing Amplitude
Description
The difference between the maximum flexion and extension of the shoulder is the arm swing amplitude during walking. The arm swing amplitude will be evaluated 2-dimensionally with the help of the Kinovea video player.
Time Frame
immediately after exercise protocol
Title
Jebsen-Taylor Hand Function Test
Description
The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). The outcome is the sum of time taken for each sub-test, which is rounded to the nearest second.
Time Frame
immediately after exercise protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be in the 10-18 ages group (In order for the devices to comply with the minimum measurement criteria and to be able to cooperate with the study) Being diagnosed with rheumatic diseases at least 6 months ago with only upper extremity affected Unilateral upper extremity involvement Exclusion Criteria: Having an acute pathology that could affect walking To be diagnosed with orthopedic/neurological pathology that will affect work and cooperation
Facility Information:
Facility Name
Istanbul University-Cerrahpaşa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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The Effect of Improvement in Function on Foot Pressure, Balance and Gait in Children With Upper Extremity Affected

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