NCT05333562

Brief Summary

The aim of this research is to find and compare the effect of Motor control exercises with and without neural mobilization on postural control of older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

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

February 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

January 21, 2022

Last Update Submit

April 11, 2022

Conditions

Keywords

Motor control exerciseNeural mobilizationpostural control

Outcome Measures

Primary Outcomes (8)

  • Static balance test

    Balance will be assessed using the Tandem stance (TS) test for static balance. The intraobserver reliability of the test is good with an ICC of 0.80.

    first reading at 0 week

  • Static balance test

    Balance will be assessed using the Tandem stance (TS) test for static balance. The intraobserver reliability of the test is good with an ICC of 0.80.

    final reading at end of 4 week

  • Gait speed test

    The 4-m gait speed test will use, and the beginning and the end of the test will mark on the floor. The intra-observer reliability of the gait speed test is excellent with an ICC of 0.91, a standard error of measurement of 0.06 m/s, and a minimum detectable difference (MDD) of 0.17 m/s.

    first reading at 0 week

  • Gait speed test

    The 4-m gait speed test will use, and the beginning and the end of the test will mark on the floor. The intra-observer reliability of the gait speed test is excellent with an ICC of 0.91, a standard error of measurement of 0.06 m/s, and a minimum detectable difference (MDD) of 0.17 m/s.

    final reading at end of 4 week

  • Timed Up and Go test

    Timing began when participants initiate standing and end when they sat down. The mean of the measurements will be use for statistical purposes. The inter-observer reliability is good with an ICC of 0.89, a standard error of measurement of 3.99 seconds, and an MDD of 11.06 seconds.

    first reading at 0 week

  • Timed Up and Go test

    Timing began when participants initiate standing and end when they sat down. The mean of the measurements will be use for statistical purposes. The inter-observer reliability is good with an ICC of 0.89, a standard error of measurement of 3.99 seconds, and an MDD of 11.06 seconds.

    final reading at 4 week

  • Quality of life: (OPQOL 35)

    OPQOL questionnaire, has been validated in a multiethnic community-dwelling older population in England. Cronbach's alpha coefficient for the Italian outpatient population enrolled in this study was found to be 0.78, i.e. above the 0.70 threshold of acceptability for internal consistency.

    first reading at 0 week

  • Quality of life: (OPQOL 35)

    OPQOL questionnaire, has been validated in a multiethnic community-dwelling older population in England. Cronbach's alpha coefficient for the Italian outpatient population enrolled in this study was found to be 0.78, i.e. above the 0.70 threshold of acceptability for internal consistency.

    final reading at 4 week

Study Arms (2)

Motor control exercise

OTHER

Motor control exercise was given with total of 8 sessions for 30 min for 4 weeks twice a day. Each exercise was performed 10 repetitions for 10 sec.

Other: Motor control exercise

Motor control exercise with neural mobilization

ACTIVE COMPARATOR

this was given motor control exercise for 30 min, 4 weeks twice a day plus neural gliding applied for 3 sets of 10 repetitions on each session. Neural gliding applied 5 min before motor control exercise. Total 8 sessions were given

Other: Motor control exercise with mobilization

Interventions

Motor control exercise was given with total of 8 sessions for 30 min for 4 weeks twice a day. Each exercise was performed 10 repetitions for 10 sec.

Motor control exercise

this was given motor control exercise for 30 min, 4 weeks twice a day plus neural gliding applied for 3 sets of 10 repetitions on each session. Neural gliding applied 5 min before motor control exercise. Total 8 sessions were given

Motor control exercise with neural mobilization

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female were included
  • Older adults having age range from 60-80 years or older
  • Adults whose score is more than 24 on mini mental state examination.
  • Ambulate independently with or without a walking aid
  • Adults who had permission from the institution's doctor to participate in exercise classes.

You may not qualify if:

  • Patients with altered conscious level
  • Adults who cannot ambulate (bed ridden patients)
  • Patient with any neurological condition like stroke, multiple sclerosis and TBI
  • Patients with severe orthopedic condition like fractures and rheumatoid arthritis
  • Patient having any cardiac condition
  • Adults walking with walking aids like sick and crutches
  • Adults having vertigo or vestibular problems.
  • Adults having history of recurrent falls.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binash Afzal

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • Plaza-Manzano G, Cancela-Cilleruelo I, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL, Thoomes-de-Graaf M, Ortega-Santiago R. Effects of Adding a Neurodynamic Mobilization to Motor Control Training in Patients With Lumbar Radiculopathy Due to Disc Herniation: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2020 Feb;99(2):124-132. doi: 10.1097/PHM.0000000000001295.

    PMID: 31464753BACKGROUND
  • Forrester LW, Roy A, Krywonis A, Kehs G, Krebs HI, Macko RF. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2014 Sep;28(7):678-87. doi: 10.1177/1545968314521004. Epub 2014 Feb 10.

    PMID: 24515923BACKGROUND
  • Aasa B, Berglund L, Michaelson P, Aasa U. Individualized low-load motor control exercises and education versus a high-load lifting exercise and education to improve activity, pain intensity, and physical performance in patients with low back pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2015 Feb;45(2):77-85, B1-4. doi: 10.2519/jospt.2015.5021.

    PMID: 25641309BACKGROUND
  • Gurpinar B, Kara B, Idiman E. Effects of aquatic exercises on postural control and hand function in Multiple Sclerosis: Halliwick versus Aquatic Plyometric Exercises: a randomised trial. J Musculoskelet Neuronal Interact. 2020 Jun 1;20(2):249-255.

    PMID: 32481240BACKGROUND
  • Silva-Batista C, Corcos DM, Kanegusuku H, Piemonte MEP, Gobbi LTB, de Lima-Pardini AC, de Mello MT, Forjaz CLM, Ugrinowitsch C. Balance and fear of falling in subjects with Parkinson's disease is improved after exercises with motor complexity. Gait Posture. 2018 Mar;61:90-97. doi: 10.1016/j.gaitpost.2017.12.027. Epub 2017 Dec 28.

    PMID: 29310015BACKGROUND
  • Halliday MH, Pappas E, Hancock MJ, Clare HA, Pinto RZ, Robertson G, Ferreira PH. A randomized clinical trial comparing the McKenzie method and motor control exercises in people with chronic low back pain and a directional preference: 1-year follow-up. Physiotherapy. 2019 Dec;105(4):442-445. doi: 10.1016/j.physio.2018.12.004. Epub 2018 Dec 21.

    PMID: 31204031BACKGROUND
  • Prasertsakul T, Kaimuk P, Chinjenpradit W, Limroongreungrat W, Charoensuk W. The effect of virtual reality-based balance training on motor learning and postural control in healthy adults: a randomized preliminary study. Biomed Eng Online. 2018 Sep 18;17(1):124. doi: 10.1186/s12938-018-0550-0.

    PMID: 30227884BACKGROUND
  • Hamed A, Bohm S, Mersmann F, Arampatzis A. Exercises of dynamic stability under unstable conditions increase muscle strength and balance ability in the elderly. Scand J Med Sci Sports. 2018 Mar;28(3):961-971. doi: 10.1111/sms.13019. Epub 2018 Feb 6.

    PMID: 29154407BACKGROUND
  • Stozek J, Rudzinska M, Pustulka-Piwnik U, Szczudlik A. The effect of the rehabilitation program on balance, gait, physical performance and trunk rotation in Parkinson's disease. Aging Clin Exp Res. 2016 Dec;28(6):1169-1177. doi: 10.1007/s40520-015-0506-1. Epub 2015 Dec 10.

    PMID: 26661467BACKGROUND
  • Mateus A, Rebelo J, Silva AG. Effects of a Multimodal Exercise Program Plus Neural Gliding on Postural Control, Pain, and Flexibility of Institutionalized Older Adults: A Randomized, Parallel, and Double-Blind Study. J Geriatr Phys Ther. 2020 Jan/Mar;43(1):3-11. doi: 10.1519/JPT.0000000000000249.

    PMID: 31569173BACKGROUND

Study Officials

  • Binash Afzal, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

April 19, 2022

Study Start

February 15, 2021

Primary Completion

October 15, 2021

Study Completion

December 15, 2021

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations