NCT04671524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

December 5, 2020

Last Update Submit

April 3, 2022

Conditions

Keywords

Upper ExtremityPhysiotherapyExerciseGaitBalance

Outcome Measures

Primary Outcomes (4)

  • 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).

    immediately after exercise protocol

  • 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.

    immediately after exercise protocol

  • 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.

    immediately after exercise protocol

  • 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.

    immediately after exercise protocol

Secondary Outcomes (2)

  • Arm Swing Amplitude

    immediately after exercise protocol

  • Jebsen-Taylor Hand Function Test

    immediately after exercise protocol

Study Arms (2)

pediatric patients diagnosed with rheumatic diseases.

EXPERIMENTAL

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

healthy controls

NO INTERVENTION

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

Interventions

a combination of stretching, range of motion, and strengthening exercise.

pediatric patients diagnosed with rheumatic diseases.

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (15)

  • Wagenaar RC, van Emmerik RE. Resonant frequencies of arms and legs identify different walking patterns. J Biomech. 2000 Jul;33(7):853-61. doi: 10.1016/s0021-9290(00)00020-8.

    PMID: 10831760BACKGROUND
  • Bruijn SM, Meijer OG, Beek PJ, van Dieen JH. The effects of arm swing on human gait stability. J Exp Biol. 2010 Dec 1;213(Pt 23):3945-52. doi: 10.1242/jeb.045112.

    PMID: 21075935BACKGROUND
  • Meyns P, Bruijn SM, Duysens J. The how and why of arm swing during human walking. Gait Posture. 2013 Sep;38(4):555-62. doi: 10.1016/j.gaitpost.2013.02.006. Epub 2013 Mar 13.

    PMID: 23489950BACKGROUND
  • Collins SH, Adamczyk PG, Kuo AD. Dynamic arm swinging in human walking. Proc Biol Sci. 2009 Oct 22;276(1673):3679-88. doi: 10.1098/rspb.2009.0664. Epub 2009 Jul 29.

    PMID: 19640879BACKGROUND
  • Pontzer H, Holloway JH 4th, Raichlen DA, Lieberman DE. Control and function of arm swing in human walking and running. J Exp Biol. 2009 Feb;212(Pt 4):523-34. doi: 10.1242/jeb.024927.

    PMID: 19181900BACKGROUND
  • Kuhtz-Buschbeck JP, Jing B. Activity of upper limb muscles during human walking. J Electromyogr Kinesiol. 2012 Apr;22(2):199-206. doi: 10.1016/j.jelekin.2011.08.014. Epub 2011 Sep 25.

    PMID: 21945656BACKGROUND
  • Yizhar Z, Boulos S, Inbar O, Carmeli E. The effect of restricted arm swing on energy expenditure in healthy men. Int J Rehabil Res. 2009 Jun;32(2):115-23. doi: 10.1097/MRR.0b013e32830d3675.

    PMID: 19065107BACKGROUND
  • Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.

    PMID: 10869131BACKGROUND
  • Meyns P, Van Gestel L, Massaad F, Desloovere K, Molenaers G, Duysens J. Arm swing during walking at different speeds in children with Cerebral Palsy and typically developing children. Res Dev Disabil. 2011 Sep-Oct;32(5):1957-64. doi: 10.1016/j.ridd.2011.03.029. Epub 2011 May 4.

    PMID: 21531534BACKGROUND
  • Stephenson JL, Lamontagne A, De Serres SJ. The coordination of upper and lower limb movements during gait in healthy and stroke individuals. Gait Posture. 2009 Jan;29(1):11-6. doi: 10.1016/j.gaitpost.2008.05.013. Epub 2008 Jul 11.

    PMID: 18620861BACKGROUND
  • Ford MP, Wagenaar RC, Newell KM. Arm constraint and walking in healthy adults. Gait Posture. 2007 Jun;26(1):135-41. doi: 10.1016/j.gaitpost.2006.08.008. Epub 2006 Sep 25.

    PMID: 16997561BACKGROUND
  • Kim HD, Kim JG, Jeon DM, Shin MH, Han N, Eom MJ, Jo GY. Analysis of Vertical Ground Reaction Force Variables Using Foot Scans in Hemiplegic Patients. Ann Rehabil Med. 2015 Jun;39(3):409-15. doi: 10.5535/arm.2015.39.3.409. Epub 2015 Jun 30.

    PMID: 26161347BACKGROUND
  • Grodner MR, Dudzinski K, Zdrajkowski Z, Molik A, Nosarzewska A. Selected gait parameters in children with obstetric brachial plexus injury (OBPI) - a pilot study. Ortop Traumatol Rehabil. 2012 Nov-Dec;14(6):555-68. doi: 10.5604/15093492.1024721.

    PMID: 23382283BACKGROUND
  • Cohen-Holzer M, Sorek G, Schless S, Kerem J, Katz-Leurer M. The Influence of a Constraint and Bimanual Training Program Using a Variety of Modalities, on Upper Extremity Functions and Gait Parameters Among Children with Hemiparetic Cerebral Palsy: A Case Series. Phys Occup Ther Pediatr. 2016;36(1):17-27. doi: 10.3109/01942638.2014.990549. Epub 2014 Dec 18.

    PMID: 25521486BACKGROUND
  • Zhou R, Alvarado L, Ogilvie R, Chong SL, Shaw O, Mushahwar VK. Non-gait-specific intervention for the rehabilitation of walking after SCI: role of the arms. J Neurophysiol. 2018 Jun 1;119(6):2194-2211. doi: 10.1152/jn.00569.2017. Epub 2018 Jan 24.

    PMID: 29364074BACKGROUND

MeSH Terms

Conditions

Gait Disorders, NeurologicArthritis, JuvenileMotor Activity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

December 5, 2020

First Posted

December 17, 2020

Study Start

September 15, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations