BalanceNCT03376334
A Pilot Study to Investigate the Effect of Motor Imagery on Dynamic Balance of Asymptomatic Students
A study testing Mental Motor Imagery in people with Balance, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
Trial summary
This study intended to investigate the effect of imagining a movement task on dynamic balance of sedentary university students. Two groups with good mental imaging ability were studied; one group receiving instructions on mental imagery and the other served as a control receiving no particular intervention. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Mental Motor Imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Oct 2014to 25 May 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No prior involvement in any physical or mental balance training
- Good mental imaging ability as determined using the motor imagery questionnaire
Who cannot join
- neuromusculoskeletal condition that may alter balance
- vestibular disorders or VBA related disorders
- painful conditions of the body
- H/o seizure, schizophrenia, meningitis, migraine, diplopia, spinal injuries, lower extremity injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Investigate the Effect of Motor Imagery on Dynamic Balance of Asymptomatic University Students: An Experimental Study
This study intended to investigate the effect of imagining a movement task on dynamic balance of sedentary university students. Two groups with good mental imaging ability were studied; one group receiving instructions on mental imagery and the other served as a control receiving no particular intervention. Any improvement in the balance ability was measured using the star excursion balance test (SEBT); for it has good to excellent test-retest reliability and validity as established by several researchers.
Read the detailed description
Motor imagery (MI) refers to a cognitive process during which the representation of a specific motor action is internally simulated without producing an overt body movement. Motor imagery is now widely used as a technique to enhance motor learning and to enhance recovery during rehabilitation of various conditions such as sports injuries, stroke, etc. Several studies have also shown improvement in strength, function, and use of both upper and lower extremities in chronic stroke. Present study aimed to identify its effectiveness in improving dynamic balance of individuals without any clinical problem. Such improvement, if any, may be useful in early balance and proprioceptive training during the maximum protection phase of joint injuries, fractures, or even rehabilitation of other clinical conditions affecting balance. It may have benefits in maintaining / improving movements in athletes after injuries as well as the general less active population, including the elderly population.
- Conditions
- Balance
- Being tested
- Mental Motor Imagery
- Keywords
- Mental motor imagery, SEBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Motor ImageryOther
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery (MI) | Experimental | Those meeting the inclusion criteria were selected (n=22). Each participant was necessary to complete the Movement Imagery Questionnaire in a quiet room. Finally, each participant assigned a score by using a 7-point scale regarding the ease/difficulty associated with representing each movement mentally. Next their baseline balance measurement was performed using the SEBT. Later this group had 9 motor imagery sessions, each session for 15 minutes, 3 sessions (alternate days) per week for a total of 3 weeks. Reassessment of balance was done after every 3 sessions. Receives: Other: Mental Motor Imagery |
| Control (C) | No intervention | Those meeting the inclusion criteria were selected (n=10). Baseline measurement of SEBT was done on day 1, end of week 1, end of week 2 and end of week 3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance
Ability to balance while performing a task i.e. lower limb reach distance is various directions measured using star excursion balance test
Measured: 24 days
Secondary outcomes (1)
Time for improvement in balance
Time required to observe a significant improvement in balance
Measured: 7 to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start2 Oct 2014
- Primary completion25 May 2015
- Study completion25 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BalanceStudies 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
- Model description
- One group received Mental Motor Imagery training, and the other group acted as a control with no specific intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pramod Divakara Shenoy, MPT, Universiti Tunku Abdul Rahman
- Investigators
- PRAMOD D SHENOY, MPT, Principal investigator, Universiti Tunku Abdul RahmanYee Mun Chang, Principal investigator, Alumnus of Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376334
- Sponsor's protocol ID
- U/SERC/40/2014
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hosseini SA, Fallahpour M, Sayadi M, Gharib M, Haghgoo H. The impact of mental practice on stroke patients' postural balance. J Neurol Sci. 2012 Nov 15;322(1-2):263-7. doi: 10.1016/j.jns.2012.07.030. Epub 2012 Aug 1.
PubMed 22857987
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Effect of Motor Imagery on Dynamic Balance of Asymptomatic University Students: An Experimental Study
- ClinicalTrials.gov ID
- NCT03376334
- Acronym / sponsor ID
- U/SERC/40/2014
- Conditions
- Balance
- Keywords
- Mental motor imagery, SEBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 2 Oct 2014 (actual)
- Primary completion
- 25 May 2015 (actual)
- Study completion
- 25 May 2015 (actual)
- First posted
- 18 Dec 2017 (actual)
- 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.
This study intended to investigate the effect of imagining a movement task on dynamic balance of sedentary university students. Two groups with good mental imaging ability were studied; one group receiving instructions on mental imagery and the other served as a control receiving no particular intervention. Any improvement in the balance ability was measured using the star excursion balance test (SEBT); for it has good to excellent test-retest reliability and validity as established by several researchers.
Detailed description
Motor imagery (MI) refers to a cognitive process during which the representation of a specific motor action is internally simulated without producing an overt body movement. Motor imagery is now widely used as a technique to enhance motor learning and to enhance recovery during rehabilitation of various conditions such as sports injuries, stroke, etc. Several studies have also shown improvement in strength, function, and use of both upper and lower extremities in chronic stroke. Present study aimed to identify its effectiveness in improving dynamic balance of individuals without any clinical problem. Such improvement, if any, may be useful in early balance and proprioceptive training during the maximum protection phase of joint injuries, fractures, or even rehabilitation of other clinical conditions affecting balance. It may have benefits in maintaining / improving movements in athletes after injuries as well as the general less active population, including the elderly population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One group received Mental Motor Imagery training, and the other group acted as a control with no specific intervention.
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery (MI) | Experimental | Other: Mental Motor ImageryThose meeting the inclusion criteria were selected (n=22). Each participant was necessary to complete the Movement Imagery Questionnaire in a quiet room. Finally, each participant assigned a score by using a 7-point scale regarding the ease/difficulty associated with representing each movement mentally. Next their baseline balance measurement was performed using the SEBT. Later this group had 9 motor imagery sessions, each session for 15 minutes, 3 sessions (alternate days) per week for a total of 3 weeks. Reassessment of balance was done after every 3 sessions. |
| Control (C) | No intervention | –Those meeting the inclusion criteria were selected (n=10). Baseline measurement of SEBT was done on day 1, end of week 1, end of week 2 and end of week 3. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- No prior involvement in any physical or mental balance training
- Good mental imaging ability as determined using the motor imagery questionnaire
Key exclusion criteria (4 listed)
- neuromusculoskeletal condition that may alter balance
- vestibular disorders or VBA related disorders
- painful conditions of the body
- H/o seizure, schizophrenia, meningitis, migraine, diplopia, spinal injuries, lower extremity injuries
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 |
|---|---|---|
| Mental Motor Imagery | Other | Motor Imagery (MI) |
Primary outcome
Dynamic Balance
Time frame: 24 days
Ability to balance while performing a task i.e. lower limb reach distance is various directions measured using star excursion balance test
1 secondary outcome
Time for improvement in balance
Time frame: 7 to 24 days
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 18 Dec 2017.
- Results publication: PubMed 22857987Hosseini SA, Fallahpour M, Sayadi M, Gharib M, Haghgoo H. The impact of mental practice on stroke patients' postural balance. J Neurol Sci. 2012 Nov 15;322(1-2):263-7. doi: 10.1016/j.jns.2012.07.030. Epub 2012 Aug 1.
- 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.
PRAMOD D SHENOY, MPT principal investigator
Universiti Tunku Abdul Rahman
Yee Mun Chang principal investigator
Alumnus of Universiti Tunku Abdul Rahman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Motor Imagery in people with Balance, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
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 18 Dec 2017. 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 Malaysia. 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?
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?
Dynamic Balance (time frame: 24 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376334, which also lists 1 linked publication.
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 18 Dec 2017.