HealthyNCT02523508
Does Passive Spinal Mobilization Improve Lower Limbs Strength and Function
A study testing Experimental group in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Previous studies have shown that peripheral muscles weakness or inhibition is related to spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle weakness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults have no active back or hip pain
Who cannot join
- Subjects with active back or hip pain
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies have shown that peripheral muscles weakness or inhibition is related to spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle weakness. The purpose of the study was to assess the effect of spinal mobilization on the maximal muscle strength of the hip flexors and motor function.
- Conditions
- Healthy
- Being tested
- Experimental group, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupBehavioural
Subject will be put into lying position, small amplitude of passive movement on the lumbar spine of the subject. The procedure will last for 1 minute.
Control groupOther
Also called Placebo
Passive limb mobilization which did not involve the spine
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Passive manual lumbar mobilization on L2-3 level Receives: Behavioral: Experimental group |
| Control group | Placebo comparator | Passive limb mobilization which did not involve the spine Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip flexor strength
The hip flexor strength measured by the hand-held dynamometer
Measured: 10 minutes after the intervention
Secondary outcomes (1)
Running speed
The running time for a 100-meter distance
Measured: 10 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LO CHI NGAI, The Hong Kong Polytechnic University
- Investigators
- Chi Ngai Lo, Master, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523508
- Sponsor's protocol ID
- HSEARS20150310003
- Status last verified
- Feb 2016
- First submitted
- 13 Aug 2015
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Passive Spinal Mobilization Improve Lower Limbs Strength and Function
- ClinicalTrials.gov ID
- NCT02523508
- Acronym / sponsor ID
- HSEARS20150310003
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have shown that peripheral muscles weakness or inhibition is related to spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle weakness. The purpose of the study was to assess the effect of spinal mobilization on the maximal muscle strength of the hip flexors and motor function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Experimental groupPassive manual lumbar mobilization on L2-3 level |
| Control group | Placebo comparator | Other: Control groupPassive limb mobilization which did not involve the spine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults have no active back or hip pain
Key exclusion criteria (1 listed)
- Subjects with active back or hip pain
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 |
|---|---|---|
| Experimental groupSubject will be put into lying position, small amplitude of passive movement on the lumbar spine of the subject. The procedure will last for 1 minute. | Behavioural | Experimental group |
| Control groupAlso: PlaceboPassive limb mobilization which did not involve the spine | Other | Control group |
Primary outcome
Hip flexor strength
Time frame: 10 minutes after the intervention
The hip flexor strength measured by the hand-held dynamometer
1 secondary outcome
Running speed
Time frame: 10 minutes after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Chi Ngai Lo, Master principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 1 inclusion and 1 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 25 Feb 2016. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hip flexor strength (time frame: 10 minutes after the intervention). 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 25 Feb 2016.