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Rebound Exercise in Neurological Disorders

Primary Purpose

Neurological Diseases or Conditions

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Rebound exercise
Sponsored by
Buckinghamshire New University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurological Diseases or Conditions focused on measuring neurological disorders, rebound, mini-trampoline, exercise /therapy, walking speed, fall risk, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of first-time stroke
  • must have passed the acute stage of stroke (6 weeks and above post-stroke)
  • must be able to walk with or without walking aids for at least 2 minutes
  • have a bodyweight <120 kg
  • must be able to understand therapy instructions.

Exclusion Criteria:

  • Pregnancy
  • other neurological/ cardiovascular system disorders
  • musculoskeletal disorders
  • visual or auditory sensory disorders.

Sites / Locations

  • Buckinghamshire New UniversityRecruiting
  • Buckinghamshire New UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rebound once-weekly

Rebound twice-weekly

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Change in baseline grip strength assessed with a digital handheld dynamometer at 12 weeks
A Hand-Held Dynamometer is a valid and reliable assessment tool used for objectively quantifying muscle strength

Full Information

First Posted
August 29, 2022
Last Updated
February 14, 2023
Sponsor
Buckinghamshire New University
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1. Study Identification

Unique Protocol Identification Number
NCT05526508
Brief Title
Rebound Exercise in Neurological Disorders
Official Title
Use of Rebound Exercise in Community-dwelling Individuals With Neurological Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Buckinghamshire New University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study will be a pretest-posttest interventional trial investigating the use of rebound exercise in community-dwelling individuals with neurological disorders.
Detailed Description
Neurological disorders are linked to various problems, including but not limited to movement impairments, balance, fear of falls, reduced exercise tolerance, loss of muscle strength, reduced functional independence, sedentary behaviour and reduced quality of life. These impairments can lead to physical deconditioning, functional dependency and extreme disability if left unmanaged, creating the need for prompt treatment. Rebound exercise is an effective and safe form of aerobic exercise that has been successfully used in some populations. It can be included in rehabilitating people with neurological disorders for its beneficial effects on humans and minimal stress on the heart and joints. Its fun-giving experience makes it easier to engage regularly compared to traditional exercise tools that may feel like a task. It is also more affordable and less time-consuming than other standard modalities. The few available studies on rebound exercise in neurological disorders were mostly in inpatients, and evidence is scarce on the use of rebound exercise in community-dwelling individuals with neurological disorders. It is thus necessary to investigate its use in the community context as well as the minimal effective dosage of the intervention. This study will investigate the frequency of rebound exercise necessary to effect changes in physiological and functional outcomes such as heart rate, blood pressure, physical activity level, walking speed, risk of falls, cognitive function and quality of life. The enrolled participants will undergo 12 weeks of rebound exercise training once or twice weekly, depending on their frequency choice. Ethical approval has been sought and obtained from the Research Ethics Committee of Buckinghamshire New University. Eligible volunteer participants will be asked to sign the informed consent after the study has been explained to them. They will be assured of data confidentiality by anonymising their information and will also be informed of their right to withdraw at any point.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Diseases or Conditions
Keywords
neurological disorders, rebound, mini-trampoline, exercise /therapy, walking speed, fall risk, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be two frequency groups, once-weekly and twice-weekly, but the group's choice depends on the participants.
Masking
Outcomes Assessor
Masking Description
Only the outcome assessor will be blinded to the participant's frequency group
Allocation
Non-Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rebound once-weekly
Arm Type
Experimental
Arm Description
This group will undergo 12 weeks of rebound exercise training once weekly, for 30 minutes per session.
Arm Title
Rebound twice-weekly
Arm Type
Experimental
Arm Description
This group will undergo 12 weeks of rebound exercise training twice weekly, for 30 minutes per session.
Intervention Type
Device
Intervention Name(s)
Rebound exercise
Intervention Description
Exercise training on the rebounder/ mini-trampoline with stability handles attached
Primary Outcome Measure Information:
Title
Change in baseline risk of fall assessed by 3-Metre Backward Walk test at 12 weeks
Description
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.
Time Frame
Baseline and12 weeks
Title
Change in baseline walking speed assessed by 10-Metre Walk test (10MWT) at 12 weeks
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in baseline quality of life assessed by World Health Organisation Quality of Life Brief version (WHOQOLBREF) at 12 weeks
Description
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.
Time Frame
Baseline and12 weeks
Title
Change in baseline physical activity level assessed by International Physical Activity Questionnaire at 12 weeks
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in baseline cognitive function assessed by mini-cog at 12 weeks
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in baseline blood pressure and heart rate assessed by digital blood pressure monitor at 12 weeks
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in baseline grip strength assessed with a digital handheld dynamometer at 12 weeks
Description
A Hand-Held Dynamometer is a valid and reliable assessment tool used for objectively quantifying muscle strength
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Pregnancy Other significant comorbidities cardiovascular or respiratory system disorders musculoskeletal disorders visual or auditory sensory disorders. cancer genu recurvatum
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adaora J Okemuo, M.Sc
Phone
07883733407
Email
Adaora.Okemuo@bucks.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yetunde M Dairo, PhD
Organizational Affiliation
Buckinghamshire New University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dearbhla Gallagher, PhD
Organizational Affiliation
Buckinghamshire New University
Official's Role
Study Chair
Facility Information:
Facility Name
Buckinghamshire New University
City
Aylesbury
State/Province
Buckinghamshire
ZIP/Postal Code
HP21 7QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adaora J Okemuo
Phone
07883733407
Email
Adaora.Okemuo@bucks.ac.uk
Facility Name
Buckinghamshire New University
City
High Wycombe
State/Province
Buckinghamshire
ZIP/Postal Code
HP11 2JZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adaora J Okemuo
Phone
07883733407
Email
Adaora.Okemuo@bucks.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The anonymised data information necessary for publication of the study findings will be shared with the researchers
Citations:
PubMed Identifier
7429911
Citation
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.
Results Reference
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PubMed Identifier
27441918
Citation
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.
Results Reference
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PubMed Identifier
30861540
Citation
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.
Results Reference
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PubMed Identifier
33197801
Citation
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.
Results Reference
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PubMed Identifier
31752634
Citation
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.
Results Reference
background
PubMed Identifier
22995379
Citation
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.
Results Reference
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PubMed Identifier
20802211
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
Centers for Disease Control and Prevention (2022). Stroke statistics. CDC Wonder Online Database. Available at www.cdc.gov/stroke/facts Retrieved 21/07/2022
Results Reference
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Citation
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
Results Reference
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Rebound Exercise in Neurological Disorders

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