The Effects of WBV on Muscle Stiffness and Reflex Activity in Stroke.

Stroke Clinical Trial

Official title:

The Effects of Whole Body Vibration (WBV) on Muscle Stiffness and Reflex Activity in People After Stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015545
• Other study ID #: HSEARS20161117007
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: December 2018
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2017
• Est. primary completion date: September 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• paretic leg-control
standing on the vibration platform, with no vibration signals delivered.
• paretic leg-WBV
standing on the vibration platform, with WBV at 30Hz, 1.5mm.
• non-paretic leg-control
standing on the vibration platform, with no vibration signals delivered.
• non-paretic leg-WBV
standing on the vibration platform, with WBV at 30Hz, 1.5mm.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hung Hom	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fugl-Meyer Assessment of Motor Recovery after Stroke--lower extremities	Evaluates and measures motor recovery in post-stroke hemiplegic patients	Immediately before the intervention
Other	Brief Balance Evaluation Systems Test		Immediately before the intervention
Primary	H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	Immediately before the intervention
Primary	H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	1st minute after the intervention
Primary	H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	2nd minute after the intervention
Primary	H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	3rd minute after the intervention
Primary	H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	4th minute after the intervention
Primary	H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	5th minute after the intervention
Primary	Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	Immediately before the intervention
Primary	Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	1st minute after the intervention
Primary	Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	2nd minute after the intervention
Primary	Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	3rd minute after the intervention
Primary	Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	4th minute after the intervention
Primary	Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	5th minute after the intervention
Primary	H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	Immediately before the intervention
Primary	H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	1st minute after the intervention
Primary	H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	2nd minute after the intervention
Primary	H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	3rd minute after the intervention
Primary	H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	4th minute after the intervention
Primary	H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	5th minute after the intervention
Primary	Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	Immediately before the intervention
Primary	Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	1st minute after the intervention
Primary	Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	2nd minute after the intervention
Primary	Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	3th minute after the intervention
Primary	Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	4th minute after the intervention
Primary	Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	5th minute after the intervention
Secondary	Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	Immediately before the intervention
Secondary	Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	1 minute after the intervention
Secondary	Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	2nd minute after the intervention
Secondary	Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	3rd minute after the intervention
Secondary	Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	4th minute after the intervention
Secondary	Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	5th minute after the intervention
Secondary	Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	Immediately before the intervention
Secondary	Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	1th minute after the intervention
Secondary	Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	2nd minute after the intervention
Secondary	Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	3rd minute after the intervention
Secondary	MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	4th minute after the intervention
Secondary	Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	5th minute after the intervention