Healthy SubjectsPhase 1NCT00776529
Combination of Strength and Sensorimotor Training
A Phase 1 study testing Sensorimotor training first, followed by strength exercises and Strength exercises and sensorimotor exercises alternated in people with Healthy Subjects, run by University of Applied Sciences of Western Switzerland at 1 site in Switzerland.
Trial summary
AIM: Strengthening and sensorimotor training (e.g with the aim to improve balance) are widely used in rehabilitation. There is little knowledge about the best ways to combine strengthening and sensorimotor training. Therefore, the investigators want to evaluate two types of combinations in healthy participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Sensorimotor training first, followed by strength exercises and Strength exercises and sensorimotor exercises alternated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2008to Dec 2008
- Phase
- Phase 1
- 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
- Able to perform strength and sensorimotor training
- At least 18 years old
Who cannot join
- Injury that does not allow training and testing
- Illness that does not allow training and testing
- Pregnancy
- Pain during exercising
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
School of Physiotherapy, University of Applied Sciences Western Switzerland, Valais
Leukerbad, Valais, 3954
About this study
Official title: Randomized Controlled Trial of Two Combinations of Strength and Sensorimotor Training: Effects on Strength, Power and Balance
AIM:
Strengthening and sensorimotor training (e.g with the aim to improve balance) are widely used in rehabilitation. There is little knowledge about the best ways to combine strengthening and sensorimotor training. Therefore, the investigators want to evaluate two types of combinations in healthy participants.
Read more
Interventions:
- Group A: 1.) warm-up; 2.) sensorimotor training; 3.) strength training (nine sessions in four weeks)
- Group B: 1.) warm-up; 2.) one strengthening exercise, followed by a sensorimotor exercise, alternating (nine sessions in four weeks)
Tests (Before first training and after four weeks):
- isokinetic test of knee extensors and flexors (60°/s; 120°/s; 180°/s; 240°/s.)
- squat jumps and countermovement jumps
- static balance test on an unstable underground (measured with accelerometer)
- dynamic balance: star excursion balance test, (a) on stable ground, (b) on unstable ground. Balance tests will be performed (c) in recovered state and (d) fatigue (i.e. after a fatiguing exercise).
Hypotheses
- Group B (alternating sensorimotor and strength exercises) will improve more in the balance tests than Group A (sensorimotor first, strength afterwards).
- Group B will improve more in the countermovement jump than Group A.
- There will be no differences in the improvements in the strength, power and squat jump tests between the two groups.
- Conditions
- Healthy Subjects
- Being tested
- Sensorimotor training first, followed by strength exercises, Strength exercises and sensorimotor exercises alternated
- Keywords
- sensorimotor training, Strengthening, Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor training first, followed by strength exercisesOther
nine sessions of one hour duration
Strength exercises and sensorimotor exercises alternatedOther
nine sessions of one hour
| Study group | Role | What they receive |
|---|---|---|
| A Sensorimotor first | Experimental | In each of nine sessions: first sensorimotor exercises, then strengthening exercises Receives: Other: Sensorimotor training first, followed by strength exercises |
| B Sensorimotor & strength alternated | Experimental | In each of nine sessions: Strength and sensorimotor exercises alternated Receives: Other: Strength exercises and sensorimotor exercises alternated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dynamic Balance measured with the Star Excursion Balance Test
Measured: From baseline to four weeks
Secondary outcomes (5)
Change in height with counter-movement jump
Measured: From baseline to four weeks
Change in height with squat jump
Measured: From baseline to four weeks
Change in force development (Nm) in knee extensors and knee flexors
Measured: From baseline to four weeks
Change in Power knee extensors and knee flexors
Measured: From baseline to four weeks
Change in Static Balance (single leg stance on unstable ground)
Measured: From baseline to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences of Western Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Jonas Meng, cand. BSc., Principal investigator, University of Applied Sciences Western Switzerland ValaisAlain Amacker, cand. BSc., Principal investigator, University of Applied Sciences of Western Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776529
- Sponsor's protocol ID
- BA06-01
- Status last verified
- Jan 2009
- First submitted
- 20 Oct 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Two Combinations of Strength and Sensorimotor Training: Effects on Strength, Power and Balance
- ClinicalTrials.gov ID
- NCT00776529
- Acronym / sponsor ID
- BA06-01
- Conditions
- Healthy Subjects
- Keywords
- sensorimotor training, Strengthening, Balance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Applied Sciences of Western SwitzerlandUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 Oct 2008 (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.
AIM:
Strengthening and sensorimotor training (e.g with the aim to improve balance) are widely used in rehabilitation. There is little knowledge about the best ways to combine strengthening and sensorimotor training. Therefore, the investigators want to evaluate two types of combinations in healthy participants.
Interventions:
- Group A: 1.) warm-up; 2.) sensorimotor training; 3.) strength training (nine sessions in four weeks)
- Group B: 1.) warm-up; 2.) one strengthening exercise, followed by a sensorimotor exercise, alternating (nine sessions in four weeks)
Tests (Before first training and after four weeks):
- isokinetic test of knee extensors and flexors (60°/s; 120°/s; 180°/s; 240°/s.)
- squat jumps and countermovement jumps
- static balance test on an unstable underground (measured with accelerometer)
- dynamic balance: star excursion balance test, (a) on stable ground, (b) on unstable ground. Balance tests will be performed (c) in recovered state and (d) fatigue (i.e. after a fatiguing exercise).
Hypotheses
- Group B (alternating sensorimotor and strength exercises) will improve more in the balance tests than Group A (sensorimotor first, strength afterwards).
- Group B will improve more in the countermovement jump than Group A.
- There will be no differences in the improvements in the strength, power and squat jump tests between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Sensorimotor first | Experimental | Other: Sensorimotor training first, followed by strength exercisesIn each of nine sessions: first sensorimotor exercises, then strengthening exercises |
| B Sensorimotor & strength alternated | Experimental | Other: Strength exercises and sensorimotor exercises alternatedIn each of nine sessions: Strength and sensorimotor exercises alternated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to perform strength and sensorimotor training
- At least 18 years old
Key exclusion criteria (4 listed)
- Injury that does not allow training and testing
- Illness that does not allow training and testing
- Pregnancy
- Pain during exercising
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 |
|---|---|---|
| Sensorimotor training first, followed by strength exercisesnine sessions of one hour duration | Other | A Sensorimotor first |
| Strength exercises and sensorimotor exercises alternatednine sessions of one hour | Other | B Sensorimotor & strength alternated |
Primary outcome
Change in Dynamic Balance measured with the Star Excursion Balance Test
Time frame: From baseline to four weeks
5 secondary outcomes
Change in height with counter-movement jump
Time frame: From baseline to four weeks
Change in height with squat jump
Time frame: From baseline to four weeks
Change in force development (Nm) in knee extensors and knee flexors
Time frame: From baseline to four weeks
Change in Power knee extensors and knee flexors
Time frame: From baseline to four weeks
Change in Static Balance (single leg stance on unstable ground)
Time frame: From baseline to four weeks
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 29 Jan 2009.
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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.
Jonas Meng, cand. BSc. principal investigator
University of Applied Sciences Western Switzerland Valais
Alain Amacker, cand. BSc. principal investigator
University of Applied Sciences of Western Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sensorimotor training first, followed by strength exercises and Strength exercises and sensorimotor exercises alternated in people with Healthy Subjects, run by University of Applied Sciences of Western Switzerland at 1 site in Switzerland.
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 2 inclusion and 4 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 29 Jan 2009. 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 Switzerland. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Dynamic Balance measured with the Star Excursion Balance Test (time frame: From baseline to four weeks). 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 29 Jan 2009; AzTrials last refreshed its copy on 3 Nov 2026.