Clinical trial NCT05526508: Rebound Exercise in Neurological Disorders
Official title: Use of Rebound Exercise in Community-dwelling Individuals With Neurological Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurological Diseases or Conditions
Keywords: neurological disorders
rebound
mini-trampoline
exercise /therapy
walking speed
fall risk
quality of life
Lead sponsor: Buckinghamshire New University
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two frequency groups, once-weekly and twice-weekly, but the group's choice depends on the participants.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in baseline risk of fall assessed by 3-Metre Backward Walk test at 12 weeks
timeFrame: Baseline and12 weeks
measure: Change in baseline walking speed assessed by 10-Metre Walk test (10MWT) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change in baseline quality of life assessed by World Health Organisation Quality of Life Brief version (WHOQOLBREF) at 12 weeks
timeFrame: Baseline and12 weeks
measure: Change in baseline physical activity level assessed by International Physical Activity Questionnaire at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change in baseline cognitive function assessed by mini-cog at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change in baseline blood pressure and heart rate assessed by digital blood pressure monitor at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in baseline grip strength assessed with a digital handheld dynamometer at 12 weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Aylesbury
country: United Kingdom
facility: Buckinghamshire New University
state: Buckinghamshire
city: High Wycombe
country: United Kingdom
facility: Buckinghamshire New University
state: Buckinghamshire
Study officials:
affiliation: Buckinghamshire New University
name: Yetunde M Dairo, PhD
role: STUDY_DIRECTOR
affiliation: Buckinghamshire New University
name: Dearbhla Gallagher, PhD
role: STUDY_CHAIR
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