Postural ControlNCT05333562
Motor Control Exercises and Neural Mobilization in Posture of Older Adults
A study of Postural Control, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to find and compare the effect of Motor control exercises with and without neural mobilization on postural control of older adults. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Postural Control
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2021to 15 Dec 2021
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female were included
- Older adults having age range from 60-80 years or older
- Adults whose score is more than 24 on mini mental state examination.
- Ambulate independently with or without a walking aid
- Adults who had permission from the institution's doctor to participate in exercise classes.
Who cannot join
- Patients with altered conscious level
- Adults who cannot ambulate (bed ridden patients)
- Patient with any neurological condition like stroke, multiple sclerosis and TBI
- Patients with severe orthopedic condition like fractures and rheumatoid arthritis
- Patient having any cardiac condition
- Adults walking with walking aids like sick and crutches
- Adults having vertigo or vestibular problems.
- Adults having history of recurrent falls.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Motor Control Exercises With and Without Neural Mobilization on Postural Control of Older Adults
The aim of this research is to find and compare the effect of Motor control exercises with and without neural mobilization on postural control of older adults.
Read the detailed description
Randomized controlled trials done at Bilqees Eidhi and Afiyat old age home Lahore.The sample size was 40. The subjects were divided in two groups, 20 subjects in Motor control exercise group and 20 in Motor control exercise with neural gliding group. Study duration was of 6 months. Sampling technique applied was purposive non probability sampling technique. Only 65-80 years of older adults included in study. Tools used in the study are time up and go test(TUG), Gait speed, Static balance and Quality of life(OPQOL35). Data was analyzed through SPSS 21.
- Conditions
- Postural Control
- Being tested
- Motor control exercise, Motor control exercise with mobilization
- Keywords
- Motor control exercise, Neural mobilization, postural control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor control exerciseOther
Motor control exercise was given with total of 8 sessions for 30 min for 4 weeks twice a day. Each exercise was performed 10 repetitions for 10 sec.
Motor control exercise with mobilizationOther
this was given motor control exercise for 30 min, 4 weeks twice a day plus neural gliding applied for 3 sets of 10 repetitions on each session. Neural gliding applied 5 min before motor control exercise. Total 8 sessions were given
| Study group | Role | What they receive |
|---|---|---|
| Motor control exercise | Other | Motor control exercise was given with total of 8 sessions for 30 min for 4 weeks twice a day. Each exercise was performed 10 repetitions for 10 sec. Receives: Other: Motor control exercise |
| Motor control exercise with neural mobilization | Active comparator | this was given motor control exercise for 30 min, 4 weeks twice a day plus neural gliding applied for 3 sets of 10 repetitions on each session. Neural gliding applied 5 min before motor control exercise. Total 8 sessions were given Receives: Other: Motor control exercise with mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance test
Balance will be assessed using the Tandem stance (TS) test for static balance. The intraobserver reliability of the test is good with an ICC of 0.80.
Measured: first reading at 0 week
Static balance test
Balance will be assessed using the Tandem stance (TS) test for static balance. The intraobserver reliability of the test is good with an ICC of 0.80.
Measured: final reading at end of 4 week
Gait speed test
The 4-m gait speed test will use, and the beginning and the end of the test will mark on the floor. The intra-observer reliability of the gait speed test is excellent with an ICC of 0.91, a standard error of measurement of 0.06 m/s, and a minimum detectable difference (MDD) of 0.17 m/s.
Measured: first reading at 0 week
Gait speed test
The 4-m gait speed test will use, and the beginning and the end of the test will mark on the floor. The intra-observer reliability of the gait speed test is excellent with an ICC of 0.91, a standard error of measurement of 0.06 m/s, and a minimum detectable difference (MDD) of 0.17 m/s.
Measured: final reading at end of 4 week
Timed Up and Go test
Timing began when participants initiate standing and end when they sat down. The mean of the measurements will be use for statistical purposes. The inter-observer reliability is good with an ICC of 0.89, a standard error of measurement of 3.99 seconds, and an MDD of 11.06 seconds.
Measured: first reading at 0 week
Timed Up and Go test
Timing began when participants initiate standing and end when they sat down. The mean of the measurements will be use for statistical purposes. The inter-observer reliability is good with an ICC of 0.89, a standard error of measurement of 3.99 seconds, and an MDD of 11.06 seconds.
Measured: final reading at 4 week
Quality of life: (OPQOL 35)
OPQOL questionnaire, has been validated in a multiethnic community-dwelling older population in England. Cronbach's alpha coefficient for the Italian outpatient population enrolled in this study was found to be 0.78, i.e. above the 0.70 threshold of acceptability for internal consistency.
Measured: first reading at 0 week
Quality of life: (OPQOL 35)
OPQOL questionnaire, has been validated in a multiethnic community-dwelling older population in England. Cronbach's alpha coefficient for the Italian outpatient population enrolled in this study was found to be 0.78, i.e. above the 0.70 threshold of acceptability for internal consistency.
Measured: final reading at 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start15 Feb 2021
- Primary completion15 Oct 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postural ControlStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333562
- Sponsor's protocol ID
- RiphahIU Raana Rubab
- Status last verified
- Apr 2022
- First submitted
- 21 Jan 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Plaza-Manzano G, Cancela-Cilleruelo I, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL, Thoomes-de-Graaf M, Ortega-Santiago R. Effects of Adding a Neurodynamic Mobilization to Motor Control Training in Patients With Lumbar Radiculopathy Due to Disc Herniation: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2020 Feb;99(2):124-132. doi: 10.1097/PHM.0000000000001295.
PubMed 31464753Forrester LW, Roy A, Krywonis A, Kehs G, Krebs HI, Macko RF. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2014 Sep;28(7):678-87. doi: 10.1177/1545968314521004. Epub 2014 Feb 10.
PubMed 24515923Aasa B, Berglund L, Michaelson P, Aasa U. Individualized low-load motor control exercises and education versus a high-load lifting exercise and education to improve activity, pain intensity, and physical performance in patients with low back pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2015 Feb;45(2):77-85, B1-4. doi: 10.2519/jospt.2015.5021.
PubMed 25641309Gurpinar B, Kara B, Idiman E. Effects of aquatic exercises on postural control and hand function in Multiple Sclerosis: Halliwick versus Aquatic Plyometric Exercises: a randomised trial. J Musculoskelet Neuronal Interact. 2020 Jun 1;20(2):249-255.
PubMed 32481240Silva-Batista C, Corcos DM, Kanegusuku H, Piemonte MEP, Gobbi LTB, de Lima-Pardini AC, de Mello MT, Forjaz CLM, Ugrinowitsch C. Balance and fear of falling in subjects with Parkinson's disease is improved after exercises with motor complexity. Gait Posture. 2018 Mar;61:90-97. doi: 10.1016/j.gaitpost.2017.12.027. Epub 2017 Dec 28.
PubMed 29310015Halliday MH, Pappas E, Hancock MJ, Clare HA, Pinto RZ, Robertson G, Ferreira PH. A randomized clinical trial comparing the McKenzie method and motor control exercises in people with chronic low back pain and a directional preference: 1-year follow-up. Physiotherapy. 2019 Dec;105(4):442-445. doi: 10.1016/j.physio.2018.12.004. Epub 2018 Dec 21.
PubMed 31204031Prasertsakul T, Kaimuk P, Chinjenpradit W, Limroongreungrat W, Charoensuk W. The effect of virtual reality-based balance training on motor learning and postural control in healthy adults: a randomized preliminary study. Biomed Eng Online. 2018 Sep 18;17(1):124. doi: 10.1186/s12938-018-0550-0.
PubMed 30227884Hamed A, Bohm S, Mersmann F, Arampatzis A. Exercises of dynamic stability under unstable conditions increase muscle strength and balance ability in the elderly. Scand J Med Sci Sports. 2018 Mar;28(3):961-971. doi: 10.1111/sms.13019. Epub 2018 Feb 6.
PubMed 29154407Stozek J, Rudzinska M, Pustulka-Piwnik U, Szczudlik A. The effect of the rehabilitation program on balance, gait, physical performance and trunk rotation in Parkinson's disease. Aging Clin Exp Res. 2016 Dec;28(6):1169-1177. doi: 10.1007/s40520-015-0506-1. Epub 2015 Dec 10.
PubMed 26661467Mateus A, Rebelo J, Silva AG. Effects of a Multimodal Exercise Program Plus Neural Gliding on Postural Control, Pain, and Flexibility of Institutionalized Older Adults: A Randomized, Parallel, and Double-Blind Study. J Geriatr Phys Ther. 2020 Jan/Mar;43(1):3-11. doi: 10.1519/JPT.0000000000000249.
PubMed 31569173
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Control Exercises With and Without Neural Mobilization on Postural Control of Older Adults
- ClinicalTrials.gov ID
- NCT05333562
- Acronym / sponsor ID
- RiphahIU Raana Rubab
- Conditions
- Postural Control
- Keywords
- Motor control exercise, Neural mobilization, postural control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 19 Apr 2022 (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.
The aim of this research is to find and compare the effect of Motor control exercises with and without neural mobilization on postural control of older adults.
Detailed description
Randomized controlled trials done at Bilqees Eidhi and Afiyat old age home Lahore.The sample size was 40. The subjects were divided in two groups, 20 subjects in Motor control exercise group and 20 in Motor control exercise with neural gliding group. Study duration was of 6 months. Sampling technique applied was purposive non probability sampling technique. Only 65-80 years of older adults included in study. Tools used in the study are time up and go test(TUG), Gait speed, Static balance and Quality of life(OPQOL35). Data was analyzed through SPSS 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor control exercise | Other | Other: Motor control exerciseMotor control exercise was given with total of 8 sessions for 30 min for 4 weeks twice a day. Each exercise was performed 10 repetitions for 10 sec. |
| Motor control exercise with neural mobilization | Active comparator | Other: Motor control exercise with mobilizationthis was given motor control exercise for 30 min, 4 weeks twice a day plus neural gliding applied for 3 sets of 10 repetitions on each session. Neural gliding applied 5 min before motor control exercise. Total 8 sessions were given |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both male and female were included
- Older adults having age range from 60-80 years or older
- Adults whose score is more than 24 on mini mental state examination.
- Ambulate independently with or without a walking aid
- Adults who had permission from the institution's doctor to participate in exercise classes.
Key exclusion criteria (8 listed)
- Patients with altered conscious level
- Adults who cannot ambulate (bed ridden patients)
- Patient with any neurological condition like stroke, multiple sclerosis and TBI
- Patients with severe orthopedic condition like fractures and rheumatoid arthritis
- Patient having any cardiac condition
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 |
|---|---|---|
| Motor control exerciseMotor control exercise was given with total of 8 sessions for 30 min for 4 weeks twice a day. Each exercise was performed 10 repetitions for 10 sec. | Other | Motor control exercise |
| Motor control exercise with mobilizationthis was given motor control exercise for 30 min, 4 weeks twice a day plus neural gliding applied for 3 sets of 10 repetitions on each session. Neural gliding applied 5 min before motor control exercise. Total 8 sessions were given | Other | Motor control exercise with neural mobilization |
Primary outcome
Static balance test
Time frame: first reading at 0 week
Balance will be assessed using the Tandem stance (TS) test for static balance. The intraobserver reliability of the test is good with an ICC of 0.80.
Static balance test
Time frame: final reading at end of 4 week
Balance will be assessed using the Tandem stance (TS) test for static balance. The intraobserver reliability of the test is good with an ICC of 0.80.
Gait speed test
Time frame: first reading at 0 week
The 4-m gait speed test will use, and the beginning and the end of the test will mark on the floor. The intra-observer reliability of the gait speed test is excellent with an ICC of 0.91, a standard error of measurement of 0.06 m/s, and a minimum detectable difference (MDD) of 0.17 m/s.
Gait speed test
Time frame: final reading at end of 4 week
The 4-m gait speed test will use, and the beginning and the end of the test will mark on the floor. The intra-observer reliability of the gait speed test is excellent with an ICC of 0.91, a standard error of measurement of 0.06 m/s, and a minimum detectable difference (MDD) of 0.17 m/s.
Timed Up and Go test
Time frame: first reading at 0 week
Timing began when participants initiate standing and end when they sat down. The mean of the measurements will be use for statistical purposes. The inter-observer reliability is good with an ICC of 0.89, a standard error of measurement of 3.99 seconds, and an MDD of 11.06 seconds.
Timed Up and Go test
Time frame: final reading at 4 week
Timing began when participants initiate standing and end when they sat down. The mean of the measurements will be use for statistical purposes. The inter-observer reliability is good with an ICC of 0.89, a standard error of measurement of 3.99 seconds, and an MDD of 11.06 seconds.
Quality of life: (OPQOL 35)
Time frame: first reading at 0 week
OPQOL questionnaire, has been validated in a multiethnic community-dwelling older population in England. Cronbach's alpha coefficient for the Italian outpatient population enrolled in this study was found to be 0.78, i.e. above the 0.70 threshold of acceptability for internal consistency.
Quality of life: (OPQOL 35)
Time frame: final reading at 4 week
OPQOL questionnaire, has been validated in a multiethnic community-dwelling older population in England. Cronbach's alpha coefficient for the Italian outpatient population enrolled in this study was found to be 0.78, i.e. above the 0.70 threshold of acceptability for internal consistency.
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 19 Apr 2022.
- Background: PubMed 31464753Plaza-Manzano G, Cancela-Cilleruelo I, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL, Thoomes-de-Graaf M, Ortega-Santiago R. Effects of Adding a Neurodynamic Mobilization to Motor Control Training in Patients With Lumbar Radiculopathy Due to Disc Herniation: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2020 Feb;99(2):124-132. doi: 10.1097/PHM.0000000000001295.
- Background: PubMed 24515923Forrester LW, Roy A, Krywonis A, Kehs G, Krebs HI, Macko RF. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2014 Sep;28(7):678-87. doi: 10.1177/1545968314521004. Epub 2014 Feb 10.
- Background: PubMed 25641309Aasa B, Berglund L, Michaelson P, Aasa U. Individualized low-load motor control exercises and education versus a high-load lifting exercise and education to improve activity, pain intensity, and physical performance in patients with low back pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2015 Feb;45(2):77-85, B1-4. doi: 10.2519/jospt.2015.5021.
- Background: PubMed 32481240Gurpinar B, Kara B, Idiman E. Effects of aquatic exercises on postural control and hand function in Multiple Sclerosis: Halliwick versus Aquatic Plyometric Exercises: a randomised trial. J Musculoskelet Neuronal Interact. 2020 Jun 1;20(2):249-255.
- Background: PubMed 29310015Silva-Batista C, Corcos DM, Kanegusuku H, Piemonte MEP, Gobbi LTB, de Lima-Pardini AC, de Mello MT, Forjaz CLM, Ugrinowitsch C. Balance and fear of falling in subjects with Parkinson's disease is improved after exercises with motor complexity. Gait Posture. 2018 Mar;61:90-97. doi: 10.1016/j.gaitpost.2017.12.027. Epub 2017 Dec 28.
- Background: PubMed 31204031Halliday MH, Pappas E, Hancock MJ, Clare HA, Pinto RZ, Robertson G, Ferreira PH. A randomized clinical trial comparing the McKenzie method and motor control exercises in people with chronic low back pain and a directional preference: 1-year follow-up. Physiotherapy. 2019 Dec;105(4):442-445. doi: 10.1016/j.physio.2018.12.004. Epub 2018 Dec 21.
- Background: PubMed 30227884Prasertsakul T, Kaimuk P, Chinjenpradit W, Limroongreungrat W, Charoensuk W. The effect of virtual reality-based balance training on motor learning and postural control in healthy adults: a randomized preliminary study. Biomed Eng Online. 2018 Sep 18;17(1):124. doi: 10.1186/s12938-018-0550-0.
- Background: PubMed 29154407Hamed A, Bohm S, Mersmann F, Arampatzis A. Exercises of dynamic stability under unstable conditions increase muscle strength and balance ability in the elderly. Scand J Med Sci Sports. 2018 Mar;28(3):961-971. doi: 10.1111/sms.13019. Epub 2018 Feb 6.
- Background: PubMed 26661467Stozek J, Rudzinska M, Pustulka-Piwnik U, Szczudlik A. The effect of the rehabilitation program on balance, gait, physical performance and trunk rotation in Parkinson's disease. Aging Clin Exp Res. 2016 Dec;28(6):1169-1177. doi: 10.1007/s40520-015-0506-1. Epub 2015 Dec 10.
- Background: PubMed 31569173Mateus A, Rebelo J, Silva AG. Effects of a Multimodal Exercise Program Plus Neural Gliding on Postural Control, Pain, and Flexibility of Institutionalized Older Adults: A Randomized, Parallel, and Double-Blind Study. J Geriatr Phys Ther. 2020 Jan/Mar;43(1):3-11. doi: 10.1519/JPT.0000000000000249.
- 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.
Binash Afzal, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Postural Control, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 8 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 19 Apr 2022. 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 Pakistan. 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?
Static balance test (time frame: first reading at 0 week). The study lists 8 primary outcomes in all. 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 NCT05333562, which also lists 10 linked publications.
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 19 Apr 2022.