Postural BalanceNCT04201691
Effect of Manuel Therapy on Tonus, Proprioseption and Balance in Multiple Sclerosis
A study testing classic rehabilitation and classic rehabilitation+mobilization in people with Postural Balance and Multiple Sclerosis, run by Tuba Maden at 1 site in Turkey (Türkiye).
Trial summary
This study is investigates the effect of cervical mobilization on tonus, position sense and balance in patient with multiple sclerosis. Half of participants will received classic rehabilitation program, while the other half will received servical mobilization in addition to classic rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postural Balance, Multiple Sclerosis, Cervical Region Disorder Nos
- What is being tested?
- classic rehabilitation and classic rehabilitation+mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2020to 30 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expanded Disability Status Scale (EDSS) score was between 2-5,
- According to the modified Ashworth Scale, spasticity is between 1 and 3,
- EDSS Cerebellar System Sub-Scale, Functional System Score ˃1,
- medical condition is stable and no medication changes were made in the last month,
- Vertebro-basillar test negative,
- Not have any other neurological disorder and orthopedic problem to prevent participation in this study
- A score of at least 24 from the Mini Mental Test,
Who cannot join
- presence of psychiatric or severe cognitive dysfunction,
- pregnancy,
- Having a neurological disease other than MS,
- having had an attack in the last 3 months,
- Botulinum toxin application within the last 6 months,
- participating in physiotherapy program in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cervical Mobilization on Tonus, Position Sense and Balance in Multiple Sclerosis Patients
This study is investigates the effect of cervical mobilization on tonus, position sense and balance in patient with multiple sclerosis. Half of participants will received classic rehabilitation program, while the other half will received servical mobilization in addition to classic rehabilitation program.
Read the detailed description
Cervical region is rich in terms of muscle spindle and reseptors. When this region is touched by physiotherapists, muscle spindles is activited. Thus position sense of joint and balance is developed. Besides, cervical region is parasympathetic area have common relaxed effect. Thus this part can be benefit to regulation of tonus.
- Conditions
- Postural Balance, Multiple Sclerosis, Cervical Region Disorder Nos, Muscle Tonus, Proprioception
- Being tested
- classic rehabilitation, classic rehabilitation+mobilization
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classic rehabilitationOther
Also called conventional rehabilitation
The intervention is conventional rehabilitation that included streching, balance and coordination training. The intervention is applied to participants, manually.
classic rehabilitation+mobilizationOther
Also called experimental rehabilitation
Another intervention is manuel therapy that included gliding technics, rotational technics at cervical region. (in addition to classic rehabilitation). The intervention is applied to participants, manually.
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Experimental | Conventional group is received conventional rehabilitation program. Receives: Other: classic rehabilitation; Other: classic rehabilitation+mobilization |
| mobilization group | Experimental | Mobilization group is received cervical mobilization in addition to conventional rehabilitation program. Receives: Other: classic rehabilitation; Other: classic rehabilitation+mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Modified ashworth scale
Modified Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. The minimum value is 1 and the maximum value is 4. Whether higher scores mean a worse outcome.
Measured: Change from Modified ashworth scale at one month
Change Berg Balance Test
The scale rates performance from 0 (cannot perform) to 4 (normal performance) on 14 items. The items explore the ability to sit, stand, lean, turn and maintain the upright position on one leg. A cut-off score of 44 was established as a criterion to identify MS subjects with a high risk of fall based on results in the literature. The minumum value is 0, the maximum value is 56. Whether higher scores mean a better outcome.
Measured: Change from Berg Balance Test at one month
Change Dynamic Gait Index
The scale measures the mobility function and the dynamic balance. The eight tasks of this scale include walking, walking with head turns, pivoting, walking over objects, walking around objects and going up stairs. The performance is rated on a 4-point scale. A score of 19 or less has been shown to be related to self-reported falls in people with vestibular disorders. The minimum value is 8, the maximum value is 24. Whether higher scores mean a better outcome.
Measured: Change from Dynamic Gait Index at one month
MyotonPRO
The MyotonPRO is a small, noninvasive hand-held apparatus that provides objective measurements of mechanical muscle properties expressed on a continuous scale. After the device probe is positioned on the skin surface above the muscle being measured, and thereby slightly compressing subcutaneous superficial tissue, it exerts a light quick released mechanical impulse. The subsequent dampened oscillation of the muscle is recorded by an accelerometer and numeric values of muscle parameters are calculated, representing the muscle tone, and biomechanical properties.
Measured: 30 days
Change The timed 25-foot walk
The T25-FW is easy to administer, is useful for a range of walking disabilities, and correlates well with other measures of walking ability. The shortening of the time indicate that the patient recovered.
Measured: Change from The timed 25-foot walk at one month
Change Functional Reach Test
A yardstick was mounted at the height of the patient's acromion. The patient was asked to stretch their arm parallel to the yardstick with fist closed. Then the patient was asked to lean forward as far a possible without taking a step. The new position of the end of the metacarpal bone was marked and the difference to the starting position was calculated. The mean value of three tries was recorded. The Functional Reach Test is a simple measurement of standing balance. Streched distance is the more longer the more better.
Measured: Change from Functional Reach Test at one month
Change Sharpened Romberg
Participants were asked to remain standing, on a straight line with one leg behind the other leg, leaving the arms sagging and without impairing the balance. Duration stop criteria were defined as the time it took a participant to dislocate the foot, reach the maximal duration of 30 sec, and contact the observer to avoid falling. Higher scores mean a better outcome.
Measured: Change from Sharpened Romberg at one month
Change Single Leg Stance Test- Right
Duration of standing was measured in participants standing with dangling arms. Maximal duration of test is 30 sec. Higher scores mean a better outcome.
Measured: Change from Single Leg Stance Test- Right at one month
Change Single Leg Stance Test- Left
Duration of standing was measured in participants standing with dangling arms. Maximal duration of test is 30 sec. Higher scores mean a better outcome.
Measured: Change from Single Leg Stance Test- Left at one month
Change Joint of position sense
Position sense was evaluated with Baseline digital goniometer. Extremity of participant is positioned to target angle and hold it there three seconds before returning to starting position. After returning to the starting position, participants attempted to repeat the previously attained angle. The measurements were repeated three times on both extremities (non-dominant and dominant) with a 30-second rest period separating trials. tests are carried out closed eyes for shoulder, ankle, knee. The angular difference is the more smaller the more better.
Measured: Change from Joint of position sense at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start7 Jan 2020
- Primary completion2 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are grouped randomly. First group and second group are applied different rehabilitation programs. Both of group is rest four weeks. Than second group is applied first group's rehabilitation program and first group is applied second group's rehabilitation program.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuba Maden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuba Maden, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201691
- Sponsor's protocol ID
- 2019/106
- Status last verified
- Aug 2021
- First submitted
- 12 Dec 2019
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cervical Mobilization on Tonus, Position Sense and Balance in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04201691
- Acronym / sponsor ID
- 2019/106
- Conditions
- Postural Balance, Multiple Sclerosis, Cervical Region Disorder Nos, Muscle Tonus, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tuba MadenUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 17 Dec 2019 (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 is investigates the effect of cervical mobilization on tonus, position sense and balance in patient with multiple sclerosis. Half of participants will received classic rehabilitation program, while the other half will received servical mobilization in addition to classic rehabilitation program.
Detailed description
Cervical region is rich in terms of muscle spindle and reseptors. When this region is touched by physiotherapists, muscle spindles is activited. Thus position sense of joint and balance is developed. Besides, cervical region is parasympathetic area have common relaxed effect. Thus this part can be benefit to regulation of tonus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are grouped randomly. First group and second group are applied different rehabilitation programs. Both of group is rest four weeks. Than second group is applied first group's rehabilitation program and first group is applied second group's rehabilitation program.
| Arm | Type | Receives |
|---|---|---|
| conventional group | Experimental | Other: classic rehabilitation, Other: classic rehabilitation+mobilizationConventional group is received conventional rehabilitation program. |
| mobilization group | Experimental | Other: classic rehabilitation, Other: classic rehabilitation+mobilizationMobilization group is received cervical mobilization in addition to conventional rehabilitation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Expanded Disability Status Scale (EDSS) score was between 2-5,
- According to the modified Ashworth Scale, spasticity is between 1 and 3,
- EDSS Cerebellar System Sub-Scale, Functional System Score ˃1,
- medical condition is stable and no medication changes were made in the last month,
- Vertebro-basillar test negative,
Key exclusion criteria (6 listed)
- presence of psychiatric or severe cognitive dysfunction,
- pregnancy,
- Having a neurological disease other than MS,
- having had an attack in the last 3 months,
- Botulinum toxin application within the last 6 months,
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 |
|---|---|---|
| classic rehabilitationAlso: conventional rehabilitationThe intervention is conventional rehabilitation that included streching, balance and coordination training. The intervention is applied to participants, manually. | Other | conventional group, mobilization group |
| classic rehabilitation+mobilizationAlso: experimental rehabilitationAnother intervention is manuel therapy that included gliding technics, rotational technics at cervical region. (in addition to classic rehabilitation). The intervention is applied to participants, manually. | Other | conventional group, mobilization group |
Primary outcome
Change Modified ashworth scale
Time frame: Change from Modified ashworth scale at one month
Modified Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. The minimum value is 1 and the maximum value is 4. Whether higher scores mean a worse outcome.
Change Berg Balance Test
Time frame: Change from Berg Balance Test at one month
The scale rates performance from 0 (cannot perform) to 4 (normal performance) on 14 items. The items explore the ability to sit, stand, lean, turn and maintain the upright position on one leg. A cut-off score of 44 was established as a criterion to identify MS subjects with a high risk of fall based on results in the literature. The minumum value is 0, the maximum value is 56. Whether higher scores mean a better outcome.
Change Dynamic Gait Index
Time frame: Change from Dynamic Gait Index at one month
The scale measures the mobility function and the dynamic balance. The eight tasks of this scale include walking, walking with head turns, pivoting, walking over objects, walking around objects and going up stairs. The performance is rated on a 4-point scale. A score of 19 or less has been shown to be related to self-reported falls in people with vestibular disorders. The minimum value is 8, the maximum value is 24. Whether higher scores mean a better outcome.
MyotonPRO
Time frame: 30 days
The MyotonPRO is a small, noninvasive hand-held apparatus that provides objective measurements of mechanical muscle properties expressed on a continuous scale. After the device probe is positioned on the skin surface above the muscle being measured, and thereby slightly compressing subcutaneous superficial tissue, it exerts a light quick released mechanical impulse. The subsequent dampened oscillation of the muscle is recorded by an accelerometer and numeric values of muscle parameters are calculated, representing the muscle tone, and biomechanical properties.
Change The timed 25-foot walk
Time frame: Change from The timed 25-foot walk at one month
The T25-FW is easy to administer, is useful for a range of walking disabilities, and correlates well with other measures of walking ability. The shortening of the time indicate that the patient recovered.
Change Functional Reach Test
Time frame: Change from Functional Reach Test at one month
A yardstick was mounted at the height of the patient's acromion. The patient was asked to stretch their arm parallel to the yardstick with fist closed. Then the patient was asked to lean forward as far a possible without taking a step. The new position of the end of the metacarpal bone was marked and the difference to the starting position was calculated. The mean value of three tries was recorded. The Functional Reach Test is a simple measurement of standing balance. Streched distance is the more longer the more better.
Change Sharpened Romberg
Time frame: Change from Sharpened Romberg at one month
Participants were asked to remain standing, on a straight line with one leg behind the other leg, leaving the arms sagging and without impairing the balance. Duration stop criteria were defined as the time it took a participant to dislocate the foot, reach the maximal duration of 30 sec, and contact the observer to avoid falling. Higher scores mean a better outcome.
Change Single Leg Stance Test- Right
Time frame: Change from Single Leg Stance Test- Right at one month
Duration of standing was measured in participants standing with dangling arms. Maximal duration of test is 30 sec. Higher scores mean a better outcome.
Change Single Leg Stance Test- Left
Time frame: Change from Single Leg Stance Test- Left at one month
Duration of standing was measured in participants standing with dangling arms. Maximal duration of test is 30 sec. Higher scores mean a better outcome.
Change Joint of position sense
Time frame: Change from Joint of position sense at one month
Position sense was evaluated with Baseline digital goniometer. Extremity of participant is positioned to target angle and hold it there three seconds before returning to starting position. After returning to the starting position, participants attempted to repeat the previously attained angle. The measurements were repeated three times on both extremities (non-dominant and dominant) with a 30-second rest period separating trials. tests are carried out closed eyes for shoulder, ankle, knee. The angular difference is the more smaller the more better.
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 10 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing classic rehabilitation and classic rehabilitation+mobilization in people with Postural Balance and Multiple Sclerosis, run by Tuba Maden at 1 site in Turkey (Türkiye).
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 7 inclusion and 6 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 10 Aug 2021. 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 Turkey (Türkiye). 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?
Change Modified ashworth scale (time frame: Change from Modified ashworth scale at one month). The study lists 10 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 10 Aug 2021.