Rebound Exercise in Neurological Disorders

Neurological Diseases or Conditions Clinical Trial

Official title:

Use of Rebound Exercise in Community-dwelling Individuals With Neurological Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526508
• Other study ID #: BNU2022Okemuo
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2023
• Source: Buckinghamshire New University
• Contact: Adaora J Okemuo, M.Sc
• Phone: 07883733407
• Email: Adaora.Okemuo[@]bucks.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Diseases or Conditions

Intervention

Device:
• Rebound exercise
Exercise training on the rebounder/ mini-trampoline with stability handles attached

Locations

Country	Name	City	State
United Kingdom	Buckinghamshire New University	Aylesbury	Buckinghamshire
United Kingdom	Buckinghamshire New University	High Wycombe	Buckinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Buckinghamshire New University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

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. — View 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. — View 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.

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

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

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	Baseline and 12 weeks