Clinical trial NCT03015545: The Effects of WBV on Muscle Stiffness and Reflex Activity in Stroke.
Official title: The Effects of Whole Body Vibration (WBV) on Muscle Stiffness and Reflex Activity in People After Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Muscle Stiffness
Ultrasound elastography
H-reflex
Whole body vibration
blood perfusion
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in the management of spastic hypertonia post-stroke. This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness, and blood perfusion in people with chronic stroke.

Detailed description: Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in management of spastic hypertonia post-stroke. However, the potential effects of WBV on leg muscle stiffness in stroke rehabilitation remains unknown. Scientific evidence is warranted to fill the knowledge gap.

Purpose This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness and blood perfusion in people with chronic stroke.

Methods Individuals with chronic stroke will be recruited from community self-help groups and existing patient database. Relevant information (e.g. demographic information, medical history) will be obtained from medical records and subject interviews. Each subject will have to fulfill the following inclusion criteria: (1) diagnosis of chronic stroke, (2) community-dwelling, (3) able to follow simple verbal instructions. Exclusion criteria are: (1) other diagnoses of neurological conditions, (2) significant musculoskeletal conditions (e.g. amputations), (3) metal implants in the lower extremity or spine, (4) recent fracture in the lower extremity, (5) diagnosis of osteoporosis, (6) vestibular disorders, (7) peripheral vascular disease, and (11) other serious illnesses or contraindications to exercise.

This is a single-blinded randomized within-patient cross-over study. Each participant was evaluated for the soleus H-reflex, stiffness and blood perfusion of the medial gastrocnemius (MG) using ultrasound on both sides before and after either a 5-minute WBV intervention (30 Hertz, 1.5mm, knee flexed 60 degrees) or a no-WBV condition (5 minutes). The measurements were performed at baseline and every 1-min post-intervention up to 5 minutes. The outcomes generated included the soleus H/M ratio, shear modulus and vascular index (VI) of the MG muscle.

Eligibility criteria: Inclusion Criteria:

1. Adult with a diagnosis of a hemispheric stroke \>6 months,
2. Medically stable,
3. Able to stand independently for at least 1 minute and
4. Mas score \>1 measured at the ankle plantar flexors.

Exclusion Criteria:

1. Brainstem or cerebellar stroke,
2. Other neurological condition,
3. Serious musculoskeletal or cardiovascular disease,
4. Severe contracture of the ankle that the cannot be put in the neutral position.
5. Metal implants or recent fractures in the lower extremities or spine,
6. Fresh skin wound in lower extremities, especially popliteal fossa
7. Other severe illnesses or contraindication for exercise.

Primary outcomes:
measure: H-reflex of paretic soleus muscle
timeFrame: Immediately before the intervention
measure: H-reflex of paretic soleus muscle
timeFrame: 1st minute after the intervention
measure: H-reflex of paretic soleus muscle
timeFrame: 2nd minute after the intervention
measure: H-reflex of paretic soleus muscle
timeFrame: 3rd minute after the intervention
measure: H-reflex of paretic soleus muscle
timeFrame: 4th minute after the intervention
measure: H-reflex of paretic soleus muscle
timeFrame: 5th minute after the intervention
measure: Muscle stiffness of paretic medial gastrocnemius
timeFrame: Immediately before the intervention
measure: Muscle stiffness of paretic medial gastrocnemius
timeFrame: 1st minute after the intervention
measure: Muscle stiffness of paretic medial gastrocnemius
timeFrame: 2nd minute after the intervention
measure: Muscle stiffness of paretic medial gastrocnemius
timeFrame: 3rd minute after the intervention
measure: Muscle stiffness of paretic medial gastrocnemius
timeFrame: 4th minute after the intervention
measure: Muscle stiffness of paretic medial gastrocnemius
timeFrame: 5th minute after the intervention
measure: H-reflex of non-paretic soleus muscle
timeFrame: Immediately before the intervention
measure: H-reflex of non-paretic soleus muscle
timeFrame: 1st minute after the intervention
measure: H-reflex of non-paretic soleus muscle
timeFrame: 2nd minute after the intervention
measure: H-reflex of non-paretic soleus muscle
timeFrame: 3rd minute after the intervention
measure: H-reflex of non-paretic soleus muscle
timeFrame: 4th minute after the intervention
measure: H-reflex of non-paretic soleus muscle
timeFrame: 5th minute after the intervention
measure: Muscle stiffness of non-paretic medial gastrocnemius
timeFrame: Immediately before the intervention
measure: Muscle stiffness of non-paretic medial gastrocnemius
timeFrame: 1st minute after the intervention
measure: Muscle stiffness of non-paretic medial gastrocnemius
timeFrame: 2nd minute after the intervention
measure: Muscle stiffness of non-paretic medial gastrocnemius
timeFrame: 3th minute after the intervention
measure: Muscle stiffness of non-paretic medial gastrocnemius
timeFrame: 4th minute after the intervention
measure: Muscle stiffness of non-paretic medial gastrocnemius
timeFrame: 5th minute after the intervention
Secondary outcomes:
measure: Intramuscular blood perfusion of paretic medial gastrocnemius muscle
timeFrame: Immediately before the intervention
measure: Intramuscular blood perfusion of paretic medial gastrocnemius muscle
timeFrame: 1 minute after the intervention
measure: Intramuscular blood perfusion of paretic medial gastrocnemius muscle
timeFrame: 2nd minute after the intervention
measure: Intramuscular blood perfusion of paretic medial gastrocnemius muscle
timeFrame: 3rd minute after the intervention
measure: Intramuscular blood perfusion of paretic medial gastrocnemius muscle
timeFrame: 4th minute after the intervention
measure: Intramuscular blood perfusion of paretic medial gastrocnemius muscle
timeFrame: 5th minute after the intervention
measure: Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
timeFrame: Immediately before the intervention
measure: Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
timeFrame: 1th minute after the intervention
measure: Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
timeFrame: 2nd minute after the intervention
measure: Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
timeFrame: 3rd minute after the intervention
measure: MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle
timeFrame: 4th minute after the intervention
measure: Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
timeFrame: 5th minute after the intervention
Other outcomes:
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke--lower extremities
timeFrame: Immediately before the intervention
measure: Brief Balance Evaluation Systems Test
timeFrame: Immediately before the intervention
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Kowloon
Study officials:
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: Hector WH Tsang, PhD
role: STUDY_CHAIR
References: