Spinal Cord InjuriesNCT02998021
Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain
A study testing Vibrating Dumbbell and Standard Dumbbell in people with Spinal Cord Injuries, run by Alicia Koontz at 1 site in United States.
Trial summary
The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Vibrating Dumbbell and Standard Dumbbell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2017to 20 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a neurological impairment secondary to spinal cord injury (SCI) or disease at T2 or lower
- greater than 6 months post injury
- use a manual wheelchair as primary means of mobility (at least 30 hrs. per week)
- 18 to 65 years of age
- provide signed medical release by primary care physician to engage in a high-intensity resistance training exercise program
- live within 60 minutes driving time (1 hour) from the research center
- able to perform a transfer independently to and from a wheelchair
- have normal range of motion in the upper limbs.
Who cannot join
- history of fractures or dislocations in the shoulder, elbow and wrist from which the subject has not fully recovered or joint replacement of any of the joints in the upper extremities
- upper limb pain that interferes with the ability to propel or transfer
- recent hospitalization for any reason (within the past three months)
- pregnant women
- history of coronary artery disease, coronary bypass surgery or other cardio-respiratory events
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15206
About this study
The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.
Read the detailed description
Objectives: The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.
Experimental Design: Design: Randomized Control Trial
Methods: Twenty subjects with paraplegia will be recruited and randomized into two groups, a vibration dumbbell training (V-DT) group and a standard dumbbell training group (S-DT). Both groups will participate in a supervised 12-week (3 sessions per week) dumbbell (free-weight) strength training program consisting of nine exercises specifically designed to improve upper limb muscle function to support propulsion and transfer activities and protect the shoulders from developing pain. For each of the nine exercises the vibration group will hold a high-frequency (40 Hz) vibrating dumbbell in a static arm posture (isometric training) while the control group will move a non-vibrating dumbbell through the full range of motion for a given exercise (isotonic training). Both groups will follow a standardized protocol for assessing and progressing the amount of weight that is added to the dumbbell to achieve optimal training effects.
All participants will participate in laboratory testing for various outcome measures at baseline, 6 weeks and 12 weeks .
- Conditions
- Spinal Cord Injuries
- Being tested
- Vibrating Dumbbell, Standard Dumbbell
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating DumbbellDevice
Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.
Standard DumbbellDevice
Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the Institutional Review Board (IRB) to cease enrolling subjects into standard dumbbell training.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training - Vibrating Dumbbell | Experimental | Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell. Receives: Device: Vibrating Dumbbell |
| Resistance Training - Standard Dumbbell | Active comparator | Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells. Receives: Device: Standard Dumbbell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Strength
Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.
Measured: Baseline and 12 weeks
Change in Upper Extremity Pain
Score generated by the Numerical Rating Scale for shoulder pain. Participants self report upper extremity pain over the last 24 hours with scores on a 0 to 10 scale. Higher scores represent higher levels of pain.
Measured: Baseline and 12 weeks
Change in General Health Measures
Score generated by the Short Form 36 walk-wheel. Participants self report on health questions within 8 domains each of which are scored from 0 to 100. The scores from each of the subscales are then averaged together to obtain an overall total score. A score of 0 represents the worst possible health state and a score of 100 represents the best possible health state.
Measured: Baseline and 12 weeks
Changes in Functional Shoulder Pain
Score generated by the Wheelchair Users Shoulder Pain Index. Participants self report shoulder pain over the past week while performing activities of daily living. Scores range from 1 to 150 where higher scores represent higher levels of pain.
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Change in Peak Speed
Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel.
Measured: Baseline and 12 weeks
Change in Acceleration
Change in acceleration (seconds) during the 250 foot level propulsion task.
Measured: Baseline and 12 weeks
Change in Peak Force
Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel.
Measured: Baseline and 12 weeks
Change in Mechanical Effective Force
Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel.
Measured: Baseline and 12 weeks
Wheelchair Transfer Ability
Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches).
Measured: Baseline and 12 weeks
Power Output
Measurement of peak power output (watts/kg) using the Load Arm Ergometer.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start15 Mar 2017
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alicia Koontz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alicia Koontz, University of Pittsburgh
- Investigators
- Alicia Koontz, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998021
- Sponsor's protocol ID
- PRO16010169
- Status last verified
- Dec 2019
- First submitted
- 13 Dec 2016
- Last updated
- 23 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain
- ClinicalTrials.gov ID
- NCT02998021
- Acronym / sponsor ID
- PRO16010169
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alicia KoontzUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Posted 23 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.
Detailed description
Objectives: The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.
Experimental Design: Design: Randomized Control Trial
Methods: Twenty subjects with paraplegia will be recruited and randomized into two groups, a vibration dumbbell training (V-DT) group and a standard dumbbell training group (S-DT). Both groups will participate in a supervised 12-week (3 sessions per week) dumbbell (free-weight) strength training program consisting of nine exercises specifically designed to improve upper limb muscle function to support propulsion and transfer activities and protect the shoulders from developing pain. For each of the nine exercises the vibration group will hold a high-frequency (40 Hz) vibrating dumbbell in a static arm posture (isometric training) while the control group will move a non-vibrating dumbbell through the full range of motion for a given exercise (isotonic training). Both groups will follow a standardized protocol for assessing and progressing the amount of weight that is added to the dumbbell to achieve optimal training effects.
All participants will participate in laboratory testing for various outcome measures at baseline, 6 weeks and 12 weeks .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Training - Vibrating Dumbbell | Experimental | Device: Vibrating DumbbellStudy participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell. |
| Resistance Training - Standard Dumbbell | Active comparator | Device: Standard DumbbellStudy participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- have a neurological impairment secondary to spinal cord injury (SCI) or disease at T2 or lower
- greater than 6 months post injury
- use a manual wheelchair as primary means of mobility (at least 30 hrs. per week)
- 18 to 65 years of age
- provide signed medical release by primary care physician to engage in a high-intensity resistance training exercise program
Key exclusion criteria (5 listed)
- history of fractures or dislocations in the shoulder, elbow and wrist from which the subject has not fully recovered or joint replacement of any of the joints in the upper extremities
- upper limb pain that interferes with the ability to propel or transfer
- recent hospitalization for any reason (within the past three months)
- pregnant women
- history of coronary artery disease, coronary bypass surgery or other cardio-respiratory events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrating DumbbellSupervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators. | Device | Resistance Training - Vibrating Dumbbell |
| Standard DumbbellSupervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators. To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the Institutional Review Board (IRB) to cease enrolling subjects into standard dumbbell training. | Device | Resistance Training - Standard Dumbbell |
Primary outcome
Change in Strength
Time frame: Baseline and 12 weeks
Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.
Change in Upper Extremity Pain
Time frame: Baseline and 12 weeks
Score generated by the Numerical Rating Scale for shoulder pain. Participants self report upper extremity pain over the last 24 hours with scores on a 0 to 10 scale. Higher scores represent higher levels of pain.
Change in General Health Measures
Time frame: Baseline and 12 weeks
Score generated by the Short Form 36 walk-wheel. Participants self report on health questions within 8 domains each of which are scored from 0 to 100. The scores from each of the subscales are then averaged together to obtain an overall total score. A score of 0 represents the worst possible health state and a score of 100 represents the best possible health state.
Changes in Functional Shoulder Pain
Time frame: Baseline and 12 weeks
Score generated by the Wheelchair Users Shoulder Pain Index. Participants self report shoulder pain over the past week while performing activities of daily living. Scores range from 1 to 150 where higher scores represent higher levels of pain.
6 secondary outcomes
Change in Peak Speed
Time frame: Baseline and 12 weeks
Change in Acceleration
Time frame: Baseline and 12 weeks
Change in Peak Force
Time frame: Baseline and 12 weeks
Change in Mechanical Effective Force
Time frame: Baseline and 12 weeks
Wheelchair Transfer Ability
Time frame: Baseline and 12 weeks
Power Output
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Koontz, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating Dumbbell and Standard Dumbbell in people with Spinal Cord Injuries, run by Alicia Koontz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Strength (time frame: Baseline and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.