Rebound Exercise in Neurological Disorders

NCT05526508 | Unknown

• 1 other identifier: BNU2022Okemuo
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

This study will be a pretest-posttest interventional trial investigating the use of rebound exercise in community-dwelling individuals with neurological disorders.

Conditions

Neurological Diseases or Conditions

Keywords

neurological disorders; rebound; mini-trampoline; exercise /therapy; walking speed; fall risk; quality of life

Outcome Measures

Primary Outcomes (6)

• Change in baseline risk of fall assessed by 3-Metre Backward Walk test at 12 weeks

  3-metre backward walk test (3MBWT) is valid, reliable and clinically suitable to detect little changes in motor functions related to proprioception in patients with neurological diseases (Kocaman et al., 2021). Of all battery tests assessed for fall risks in patients with Parkinson's disease (Carter et al., 2020), 3MBWT had the highest overall accuracy for retrospective falls. Backward walking measures are more sensitive to identify age-related changes in mobility than forward walking. From a marked point, the patient is asked to walk backwards as fast and safely as possible to a 3-metre marked end. They are free to look back if they wish. A time of 3 seconds or less indicates good balance and low fall risk, while a time of 4.5 seconds or more indicates a high fall risk.

  Baseline and12 weeks

• Change in baseline walking speed assessed by 10-Metre Walk test (10MWT) at 12 weeks

  10MWT has been shown to have excellent construct validity and reliability for patients with neurological diseases (Cheng et al., 2020). The individual is instructed to walk a set distance of 10 meters, and the time taken to walk the distance is noted. Assistive devices may be used but must be documented from test to test. Walking distance is measured in meters per second.

  Baseline and 12 weeks

• Change in baseline quality of life assessed by World Health Organisation Quality of Life Brief version (WHOQOLBREF) at 12 weeks

  WHOQOLBREF is a 12-item questionnaire assessing physical and psychological domains of quality of life. The scale has been validated among stroke patients of different ethnic groups (Kerber et al., 2013; Post et al., 2011). It is rated on a 5-point Likert scale ranging from 1-5, with higher scores indicating better quality of life. A significant advantage it has over the more extended version is its reduced administration time (5 minutes), making it a more practical tool in research and clinical practice.

  Baseline and12 weeks

• Change in baseline physical activity level assessed by International Physical Activity Questionnaire at 12 weeks

  The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients. The IPAQ can be used clinically and in population research that compares physical activity levels between populations internationally.

  Baseline and 12 weeks

• Change in baseline cognitive function assessed by mini-cog at 12 weeks

  The Mini-Cog is a simple screening test for cognitive impairment. It combines a brief memory test and a scored clock-drawing test. It allows rapid screening for short-term memory defects, learning and different cognitive abilities impaired in dementia patients.

  Baseline and 12 weeks

• Change in baseline blood pressure and heart rate assessed by digital blood pressure monitor at 12 weeks

  A digital Blood pressure monitor uses an inflatable air-bladder cuff, a battery-powered air pump and a pressure sensor for sensing arterial wall vibrations to measure blood pressure in an artery.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Change in baseline grip strength assessed with a digital handheld dynamometer at 12 weeks

  Baseline and 12 weeks

Study Arms (2)

Rebound once-weekly

EXPERIMENTAL

This group will undergo 12 weeks of rebound exercise training once weekly, for 30 minutes per session.

Device: Rebound exercise

Rebound twice-weekly

EXPERIMENTAL

This group will undergo 12 weeks of rebound exercise training twice weekly, for 30 minutes per session.

Device: Rebound exercise

Interventions

Rebound exercise DEVICE

Exercise training on the rebounder/ mini-trampoline with stability handles attached

Rebound once-weekly; Rebound twice-weekly

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of a neurological disorder of upper motor neurone origin such as stroke, multiple sclerosis, Parkinson's disease, traumatic brain injury etc
• must score 3 or less on the Modified Rankin Scale for disability status
• must be able to walk with or without walking aids for at least 2 minutes
• have a body weight of \<120 kg
• must be able to understand therapy instructions.

You may not qualify if:

• Pregnancy
• Other significant comorbidities
• cardiovascular or respiratory system disorders
• musculoskeletal disorders
• visual or auditory sensory disorders.
• cancer
• genu recurvatum

Sponsors & Collaborators

• Buckinghamshire New University: lead

Study Sites (2)

Buckinghamshire New University

Aylesbury, Buckinghamshire, HP21 7QG, United Kingdom

RECRUITING

Buckinghamshire New University

High Wycombe, Buckinghamshire, HP11 2JZ, United Kingdom

RECRUITING

Related Publications (10)

• Bhattacharya A, McCutcheon EP, Shvartz E, Greenleaf JE. Body acceleration distribution and O2 uptake in humans during running and jumping. J Appl Physiol Respir Environ Exerc Physiol. 1980 Nov;49(5):881-7. doi: 10.1152/jappl.1980.49.5.881.

  PMID: 7429911 BACKGROUND

• Cugusi L, Manca A, Serpe R, Romita G, Bergamin M, Cadeddu C, Solla P, Mercuro G; Working Group of Gender Cardiovascular Disease of the Italian Society of Cardiology. Effects of a mini-trampoline rebounding exercise program on functional parameters, body composition and quality of life in overweight women. J Sports Med Phys Fitness. 2018 Mar;58(3):287-294. doi: 10.23736/S0022-4707.16.06588-9. Epub 2016 Jul 21.

  PMID: 27441918 BACKGROUND

• Unver B, Sevik K, Yarar HA, Unver F, Karatosun V. Reliability of 3-m Backward Walk Test in Patients with Primary Total Knee Arthroplasty. J Knee Surg. 2020 Jun;33(6):589-592. doi: 10.1055/s-0039-1681099. Epub 2019 Mar 12.

  PMID: 30861540 BACKGROUND

• Abit Kocaman A, Aydogan Arslan S, Ugurlu K, Katirci Kirmaci ZI, Keskin ED. Validity and Reliability of The 3-Meter Backward Walk Test in Individuals with Stroke. J Stroke Cerebrovasc Dis. 2021 Jan;30(1):105462. doi: 10.1016/j.jstrokecerebrovasdis.2020.105462. Epub 2020 Nov 13.

  PMID: 33197801 BACKGROUND

• Cheng DK, Nelson M, Brooks D, Salbach NM. Validation of stroke-specific protocols for the 10-meter walk test and 6-minute walk test conducted using 15-meter and 30-meter walkways. Top Stroke Rehabil. 2020 May;27(4):251-261. doi: 10.1080/10749357.2019.1691815. Epub 2019 Nov 21.

  PMID: 31752634 BACKGROUND

• Kerber KA, Brown DL, Skolarus LE, Morgenstern LB, Smith MA, Garcia NM, Lisabeth LD. Validation of the 12-item stroke-specific quality of life scale in a biethnic stroke population. J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1270-2. doi: 10.1016/j.jstrokecerebrovasdis.2012.08.011. Epub 2012 Sep 18.

  PMID: 22995379 BACKGROUND

• Post MW, Boosman H, van Zandvoort MM, Passier PE, Rinkel GJ, Visser-Meily JM. Development and validation of a short version of the Stroke Specific Quality of Life Scale. J Neurol Neurosurg Psychiatry. 2011 Mar;82(3):283-6. doi: 10.1136/jnnp.2009.196394. Epub 2010 Aug 27.

  PMID: 20802211 BACKGROUND

• Burandt P, Porcari JP, Cress ML, Doberstein S, Foster C, Green DJ (2016). ACE-Sponsored research: Putting mini-trampolines to the test. ACE Prosource. Available at www.acefitness.org Retrieved on 21/07/2022.

  BACKGROUND

• Centers for Disease Control and Prevention (2022). Stroke statistics. CDC Wonder Online Database. Available at www.cdc.gov/stroke/facts Retrieved 21/07/2022

  BACKGROUND

• Carter, V.A., Farley, B.G., Wing, K. and Jain, T.K., 2020. Diagnostic accuracy of the 3-meter backward walk test in persons with parkinson disease. Topics in Geriatric Rehabilitation, 36(3), pp.140-145

  BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Yetunde M Dairo, PhD

  Buckinghamshire New University

  STUDY DIRECTOR

• Dearbhla Gallagher, PhD

  Buckinghamshire New University

  STUDY CHAIR

Central Study Contacts

Adaora J Okemuo, M.Sc

CONTACT

07883733407; Adaora.Okemuo@bucks.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcome assessor will be blinded to the participant's frequency group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Lecturer, PhD research student, School of Health and Social Care Professions

Model Details: There will be two frequency groups, once-weekly and twice-weekly, but the group's choice depends on the participants.

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 2, 2022
• Study Start: December 12, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

GB (2)