NCT01983631

Brief Summary

The Cerebellum contains ten percent of the total volume of the brain and receives brain, spinal cord and vestibular sensory input. The organization of vestibular and somato-sensory afferent informations are also reported to be impaired in patients with cerebellum dysfunctions. Ataxia and impaired balance control are common symptoms in individuals with spinocerebellar ataxia (SCA). Previous studies have shown that patient with cerebellar damage are usually agonist and antagonist muscle coordination problem. Past studies also found the regulation of reciprocal Ia inhibition was impaired in patients with spinaocerebellar ataxia. In chronic phase, weakness might be developed due to deconditioned. All deficits mentioned above might lead to a decrease functional ability. Therefore, increasing somato-sensory and vestibular input, normalizing the modulation of recriprocal inhibition, and improve muscle strength might be able to improve the functional abilities of individuals with SCA. Recently, whole body vibration (WBV) has been trained for health groups. Studies showed that WBV training were able to improve muscle strength, balance control, and functional ability. However, there is no evidence showed that whether the whole body vibration training can affect the brain and spinal cord for the regulation of neural circuits. Whether also can affect for maximal voluntary contraction and improve central fatigue. No previous studies that whole body vibration training for SCA. Therefore, the purpose of this research was to investigate the intracortical facilitation and inhibition, reciprocal Ia inhibition, low frequency depression, maximal voluntary contraction, interpolated twitch technique to compare the different between the SCA and health subject. Also to investigate the short term and long term effect of WBV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

1.9 years

First QC Date

November 7, 2013

Last Update Submit

November 13, 2013

Conditions

Keywords

Whole body vibrationReciprocal inhibitionSpinocerebellar ataxiavoluntary activation level

Outcome Measures

Primary Outcomes (4)

  • Muscle twitch force

    Measure of changes in muscle twitch force by interpolation twitch technique

    Baseline, 4 weeks.

  • Muscle voluntary activity level

    Measure of changes in muscle voluntary activity level by interpolation twitch technique.

    Baseline, 4 weeks

  • Balance

    Measure of changes in berge balance scale and one-leg standing.

    Baseline, 4 weeks

  • Severity of cerebellar ataxia

    Measure of changes in international cooperative ataxia rating scale(ICARS).

    Baseline, 4 weeks

Study Arms (4)

WBV group

EXPERIMENTAL

Stage 1: Short-term Whole body vibration(3 minutes in half-squatting position)

Other: Whole body vibration training

Non-WBV group

NO INTERVENTION

Stage 1 : Controlled group

training group

EXPERIMENTAL

Stage 2: Long-term WBV training (3 sessions per week for 4 weeks)

Other: Whole body vibration training

non-training group

NO INTERVENTION

Stage 2: Controlled group

Interventions

WBV grouptraining group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of spinocerebellar ataxia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Spinocerebellar Ataxias

Condition Hierarchy (Ancestors)

Cerebellar AtaxiaCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinocerebellar DegenerationsSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesAtaxiaDyskinesiasNeurologic ManifestationsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 14, 2013

Study Start

April 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations