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Completed

NCT Number: NCT00937339

Effects of Whole Body Vibration in People With Chronic Stroke

The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone health, physical fitness and neuromotor performance in patients with chronic stroke.

Subjects in the experimental group will undergo whole body vibration therapy (1 session per day, 3 sessions per week) for 8 weeks. The vibration frequency used in this study will be 30Hz. The total duration of exposure to vibration for the experimental group will be 10 minutes. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2) deep squatting, (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The control exercise group, on the other hand, will perform the same exercise program on the platform, but no vibration will be given. The training will be conducted by a qualified personnel with physiotherapy background.

The outcome measurement will be performed 4 times: (1) immediately before the commencement of intervention, (2) immediately after termination of treatment, (3) at 1 month after termination of treatment. Each subject will be evaluated for bone markers, leg muscle strength, balance, spasticity, and walking ability.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Polytechnic University

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a diagnosis of stroke more than 6 months
  • medically stable
  • able to understand verbal commands
  • Abbreviated mental test score 6 or above
  • age >18
  • able to stand with or without aids for at least 1.5 minutes

Exclusion criteria

  • neurological conditions other than stroke
  • significant musculoskeletal conditions (e.g. amputations)
  • metal implants in the lower extremity
  • previous fracture of the lower extremity
  • are currently taking bone resorption inhibitors or were taking the same before stroke.
  • significant peripheral vascular disease
  • vestibular disorders
  • pregnancy
  • Other serious illnesses that preclude the person from participating in the study

Treatment and study plan

Whole Body Vibration Therapy

Device

Experimental group: One session per day, 3 sessions per week, for consecutive 8 weeks. The total duration of whole body vibration therapy will be about 10 minutes per session.

Other names: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)

Exercise on the vibration platform with the device turned off

Device

Control group: One session per day, 3 sessions per week, for consecutive 8 weeks. The subjects will perform the same exercises on the vibration platform but no vibration will be applied.

Other names: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)

Primary outcomes

  1. Paretic knee concentric muscle strength

    Time frame: pre-test (week 0)

  2. Paretic knee concentric muscle strength

    Time frame: Post-test (week 8)

  3. Paretic knee concentric muscle strength

    Time frame: Follow-up (week 12)

Secondary outcomes

  1. Non-paretic concentric knee muscle strength

    Time frame: Pre-test (week 0)

  2. Non-paretic knee concentric muscle strength

    Time frame: Post-test (week 8)

  3. Non-paretic knee concentric muscle strength

    Time frame: Follow-up (week 12)

  4. Paretic knee eccentric muscle strength

    Time frame: pre-test (week 0)

  5. Paretic knee eccentric muscle strength

    Time frame: Post-test (week 8)

  6. Paretic knee eccentric muscle strength

    Time frame: WFollow-up (week 12)

  7. Non-paretic knee eccentric muscle strength

    Time frame: Pre-test (week 0)

  8. Non-paretic knee eccentric muscle strength

    Time frame: Post-test (week 8)

  9. Non-paretic knee eccentric muscle strength

    Time frame: Follow-up (week 12)

  10. Paretic knee isometric muscle strength

    Time frame: Pre-test (week 0)

  11. Paretic knee isometric muscle strength

    Time frame: Post-test (week 8)

  12. Paretic knee isometric muscle strength

    Time frame: Follow-up (week 12)

  13. Non-paretic knee isometric muscle strength

    Time frame: Pre-test (week 0)

  14. Non-paretic knee isometric muscle strength

    Time frame: Post-test (week 8)

  15. Non-paretic knee isometric muscle strength

    Time frame: Follow-up (week 12)

  16. Limit of stability test

    Time frame: Pre-test (week 0)

  17. Limit of stability test

    Time frame: Post-test (week 8)

  18. Limit of stability test

    Time frame: Follow-up (week 12)

  19. Berg balance test

    Time frame: Pre-test (week 0)

  20. Berg balance test

    Time frame: Post-test (week 12)

  21. Berg balance test

    Time frame: Follow-up (week 12)

  22. Activities-specific Balance Confidence Scale

    Time frame: Pre-test (week 0)

  23. Activities-specific Balance Confidence Scale

    Time frame: Post-test (week 8)

  24. Activities-specific Balance Confidence Scale

    Time frame: Follow-up (week 12)

  25. Six Minute Walk Test

    Time frame: Pre-test (week 0)

  26. Six Minute Walk Test

    Time frame: Post-test (week 8)

  27. Six Minute Walk Test

    Time frame: Follow-up (week 12)

  28. Self-selected gait velocity

    Time frame: Pre-test (week 0)

  29. Self-selected gait velocity

    Time frame: post-test (week 8)

  30. Self-selected gait velocity

    Time frame: Follow-up (week 12)

  31. Bone formation marker level

    Time frame: pre-test (week 0)

  32. Bone formation marker level

    Time frame: Post-test (week 8)

  33. Bone resorption marker level

    Time frame: pre-test (week 0)

  34. Bone formation marker level

    Time frame: Follow-up (week 12)

  35. Bone resorption marker level

    Time frame: post-test (week 8)

  36. Bone resorption marker level

    Time frame: Follow-up (week 12)

  37. fall rate

    Time frame: 6 months after termination of treatment

  38. Knee spasticity

    Time frame: Pre-test (week 0)

  39. Knee spasticity

    Time frame: Post-test (week 8)

  40. Knee spasticity

    Time frame: Follow-up (week 12)

  41. Ankle spasticity

    Time frame: Pre-test (week 0)

  42. Ankle spasticity

    Time frame: Post-test (week 8)

  43. Ankle spasticity

    Time frame: Follow-up (week 12)

  44. Level of satisfaction

    Time frame: Post-test (week 8)

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

The Effects of Exercise and Whole Body Vibration Training on Bone Health, Physical Fitness, and Neuromotor Performance in Individuals With Chronic Stroke: A Randomized Controlled Trial.

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jul 13, 2009
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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