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

April 3, 2022 updated by: Gokce Leblebici, Istanbul University - Cerrahpasa (IUC)

Investigation of the Effect of Improvement in Function on Foot Pressure, Balance and Gait in Children With Rheumatic Diseases Whose Upper Extremity Affected

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pediatric patients diagnosed with rheumatic diseases.

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.
Other: Exercise protocol
a combination of stretching, range of motion, and strengthening exercise.
No Intervention: healthy controls
The healthy control group will be examined and the outcomes will be compared with the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall risk
Time Frame: immediately after exercise protocol
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).
immediately after exercise protocol
Postural Stability
Time Frame: immediately after exercise protocol
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.
immediately after exercise protocol
Bilateral Comparison
Time Frame: immediately after exercise protocol
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.
immediately after exercise protocol
Single limb stance
Time Frame: immediately after exercise protocol
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.
immediately after exercise protocol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arm Swing Amplitude
Time Frame: immediately after exercise protocol
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.
immediately after exercise protocol
Jebsen-Taylor Hand Function Test
Time Frame: immediately after exercise protocol
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.
immediately after exercise protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

December 5, 2020

First Submitted That Met QC Criteria

December 12, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulUC_34_2

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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