Cognitive ImpairmentNCT06927362
LSVT Big and Dual Task Training in Cognitive Impaired Patients
A study testing Lee Silverman treatment big and Dual task training in people with Cognitive Impairment and Balance Changes, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this study ifs to determine the comparative effects of Lee Silverman voice treatment Big and dual task training on balance, cognition and functional mobility in older adults with cognitive impairment. Perform LSVT big four times in a week for about 4 months. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Balance Changes, Cognition Disorders in Old Age
- What is being tested?
- Lee Silverman treatment big and Dual task training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Both male and female patients.
- Age limit for patients will be above 65.
- Patients with Mild and moderate cognitive impairment patients MoCA 13-25.
- Patients with Berge balance scale value 41-50.
- Patients who give consent to participate in study and undergo relevant test.
Who cannot join
- Patients with any musculoskeletal disorder in which these exercises are contraindicated.
- Patients using any walking aids.
- Patients with hearing impairment.
- Patients with other neurological conditions with limit the patient participation in planned exercise like stroke, Parkinson's.
- Patients with diagnosed psychiatric disorder or taking medication that affect cognitive function within 24 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Iqra Medical Complex and Irtiqa Fitness Club
Lahore, Punjab Province, 54660
Aruba Saeed, 344399403, arubasaeedpt@gmail.com
About this study
Official title: Effects of Lee Silverman Voice Treatment Big and Dual Task Training on Balance, Cognition and Functional Mobility in Older Adults With Cognitive Impairment.
The goal of this study ifs to determine the comparative effects of Lee Silverman voice treatment Big and dual task training on balance, cognition and functional mobility in older adults with cognitive impairment.
Perform LSVT big four times in a week for about 4 months. Perform dual task training four times in a week for about 4 months. Complete assessments at baseline, the 4th, 8th, 12th weeks, and a follow-up at the 16th week.
Outcome measures include Mini BESTest, MoCA, stroop test and time up and go test. Statistical analyses will assess within-group and between-group effects based on data distribution.
Read the detailed description
This study, titled "Effects of of lee Silverman voice treatment big and dual task training on balance, cognition and functional mobility in older adults with cognitive impairment" aims to assess the combined effectiveness of Lee Silverman voice treatment and dual task training in older adults with cognitive impairment.
- Conditions
- Cognitive Impairment, Balance Changes, Cognition Disorders in Old Age, Functional Mobility
- Being tested
- Lee Silverman treatment big, Dual task training
- Keywords
- LSVT big, dual task training, cognitive impaired patients, cognition
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lee Silverman treatment bigOther
Half of the treatment sessions consist of standardized multidirectional whole-body movements performed with maximal amplitude of reaching and stepping. The second half is designed to address individual deficits in movement that occur in activities of daily living.
Dosage: 4 consecutive days a week for 12 weeks (16 sessions in one month) for 60 minutes Repetitions: minimum 8-16 repetitions/task
Dual task trainingOther
Group B will receive cognitive motor dual task training for 60 minutes, 4 times a week for 12 weeks. The intervention include both motor and cognitive components.
| Study group | Role | What they receive |
|---|---|---|
| Group A (LSVT BIG) | Experimental | Group A will receive SLVT BIG intervention for 12 week (4 times per week) for 60 minutes Receives: Other: Lee Silverman treatment big |
| Group B ( Dual task training) | Experimental | Group B will receive cognitive motor dual task training for 12 weeks (4 times per week) for 60 minutes. Receives: Other: Dual task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini BESTest
It is a short form of the BESTest which include 14 items only. The Mini-BESTest includes asses aspects of dynamic balance control also and control while walking and performing a cognitive task.
Measured: 4th week
MoCA (Montreal Cognitive Assessment (For Cognition)
The Montreal Cognitive Assessment (MoCA) is cognitive screening tool which include 30 points. It measures visuospatial, short term memory, orientation, language, executive functioning along with attention/concentration/working memory.
Measured: 4th week
Stroop test
The Stroop task is one of the most widely used measures of cognitive functioning. The Stroop test requires participants to name the color in which a presented word is printed. Numerous studies have shown that participants need more time to name ink colors of incongruent words than to name ink colors of control patches.
Measured: 4th week
Time up and go test
Timed Up and Go (TUG) have been used in clinical settings as a measure of physical performance in older adults with and without cognitive dysfunction. This test requires people to stand up from a chair, walk 3 m, turn around, walk back to the chair, and sit down again.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start10 Apr 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies 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
- Model description
- interventional study model for this study is a parallel-group randomized controlled trial (RCT). This model involves two distinct groups: Group A will receive SLVT BIG intervention and group B will receive cognitive motor dual task training. Warm up and stretching exercises will be done for both groups. comparisons between two therapies are unbiased. This parallel structure means each group undergoes its specific intervention throughout the study period without crossover to the other group's intervention. This approach helps assess the difference in effects of the two therapies on balance, cognition and functional mobility in older adults with cognitive impairment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arooba Saeed, phD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927362
- Sponsor's protocol ID
- REC/0258 Rabia Aslam
- Status last verified
- Aug 2025
- First submitted
- 7 Apr 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park MO, Lee SH. Effects of cognitive-motor dual-task training combined with auditory motor synchronization training on cognitive functioning in individuals with chronic stroke: A pilot randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(22):e10910. doi: 10.1097/MD.0000000000010910.
PubMed 29851819Janssens J, Malfroid K, Nyffeler T, Bohlhalter S, Vanbellingen T. Application of LSVT BIG intervention to address gait, balance, bed mobility, and dexterity in people with Parkinson disease: a case series. Phys Ther. 2014 Jul;94(7):1014-23. doi: 10.2522/ptj.20130232. Epub 2014 Feb 20.
PubMed 24557655Morris S, Morris ME, Iansek R. Reliability of measurements obtained with the Timed "Up & Go" test in people with Parkinson disease. Phys Ther. 2001 Feb;81(2):810-8. doi: 10.1093/ptj/81.2.810.
PubMed 11175678Daniel B, Agenagnew L, Workicho A, Abera M. Psychometric Properties of the Montreal Cognitive Assessment (MoCA) to Detect Major Neurocognitive Disorder Among Older People in Ethiopia: A Validation Study. Neuropsychiatr Dis Treat. 2022 Aug 22;18:1789-1798. doi: 10.2147/NDT.S377430. eCollection 2022.
PubMed 36035074Das S, Mitra K, Mandal M. Sample size calculation: Basic principles. Indian J Anaesth. 2016 Sep;60(9):652-656. doi: 10.4103/0019-5049.190621.
PubMed 27729692Kim JH, Park JH. Does Cognitive-Physical Dual-Task Training Have Better Clinical Outcomes than Cognitive Single-Task Training Does? A Single-Blind, Randomized Controlled Trial. Healthcare (Basel). 2023 May 25;11(11):1544. doi: 10.3390/healthcare11111544.
PubMed 37297684Parial LL, Kor PPK, Sumile EF, Leung AYM. Dual-Task Zumba Gold for Improving the Cognition of People With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial. Gerontologist. 2023 Aug 24;63(7):1248-1261. doi: 10.1093/geront/gnac081.
PubMed 35679826Kaya Aytutuldu G, Ersoz Huseyinsinoglu B, Karagoz Sakalli N, Sen A, Yeldan I. LSVT(R) BIG versus progressive structured mobility training through synchronous telerehabilitation in Parkinson's disease: A randomized controlled trial. Neurol Sci. 2024 Jul;45(7):3163-3172. doi: 10.1007/s10072-024-07322-0. Epub 2024 Jan 25.
PubMed 38267603Peterka M, Odorfer T, Schwab M, Volkmann J, Zeller D. LSVT-BIG therapy in Parkinson's disease: physiological evidence for proprioceptive recalibration. BMC Neurol. 2020 Jul 11;20(1):276. doi: 10.1186/s12883-020-01858-2.
PubMed 32652957Huang X, Zhao X, Li B, Cai Y, Zhang S, Wan Q, Yu F. Comparative efficacy of various exercise interventions on cognitive function in patients with mild cognitive impairment or dementia: A systematic review and network meta-analysis. J Sport Health Sci. 2022 Mar;11(2):212-223. doi: 10.1016/j.jshs.2021.05.003. Epub 2021 May 16.
PubMed 34004389Farhang M, Miranda-Castillo C, Rubio M, Furtado G. Impact of mind-body interventions in older adults with mild cognitive impairment: a systematic review. Int Psychogeriatr. 2019 May;31(5):643-666. doi: 10.1017/S1041610218002302. Epub 2019 Feb 4.
PubMed 30712518Kim O, Pang Y, Kim JH. The effectiveness of virtual reality for people with mild cognitive impairment or dementia: a meta-analysis. BMC Psychiatry. 2019 Jul 12;19(1):219. doi: 10.1186/s12888-019-2180-x.
PubMed 31299921Veldkamp R, Baert I, Kalron A, Tacchino A, D'hooge M, Vanzeir E, Van Geel F, Raats J, Goetschalckx M, Brichetto G, Shalmoni N, Hellinckx P, De Weerdt N, De Wilde D, Feys P. Structured Cognitive-Motor Dual Task Training Compared to Single Mobility Training in Persons with Multiple Sclerosis, a Multicenter RCT. J Clin Med. 2019 Dec 10;8(12):2177. doi: 10.3390/jcm8122177.
PubMed 31835502
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lee Silverman Voice Treatment Big and Dual Task Training on Balance, Cognition and Functional Mobility in Older Adults With Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT06927362
- Acronym / sponsor ID
- REC/0258 Rabia Aslam
- Conditions
- Cognitive Impairment, Balance Changes, Cognition Disorders in Old Age, Functional Mobility
- Keywords
- LSVT big, dual task training, cognitive impaired patients, cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Apr 2025 (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 goal of this study ifs to determine the comparative effects of Lee Silverman voice treatment Big and dual task training on balance, cognition and functional mobility in older adults with cognitive impairment.
Perform LSVT big four times in a week for about 4 months. Perform dual task training four times in a week for about 4 months. Complete assessments at baseline, the 4th, 8th, 12th weeks, and a follow-up at the 16th week.
Outcome measures include Mini BESTest, MoCA, stroop test and time up and go test. Statistical analyses will assess within-group and between-group effects based on data distribution.
Detailed description
This study, titled "Effects of of lee Silverman voice treatment big and dual task training on balance, cognition and functional mobility in older adults with cognitive impairment" aims to assess the combined effectiveness of Lee Silverman voice treatment and dual task training in older adults with cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- interventional study model for this study is a parallel-group randomized controlled trial (RCT). This model involves two distinct groups: Group A will receive SLVT BIG intervention and group B will receive cognitive motor dual task training. Warm up and stretching exercises will be done for both groups. comparisons between two therapies are unbiased. This parallel structure means each group undergoes its specific intervention throughout the study period without crossover to the other group's intervention. This approach helps assess the difference in effects of the two therapies on balance, cognition and functional mobility in older adults with cognitive impairment.
| Arm | Type | Receives |
|---|---|---|
| Group A (LSVT BIG) | Experimental | Other: Lee Silverman treatment bigGroup A will receive SLVT BIG intervention for 12 week (4 times per week) for 60 minutes |
| Group B ( Dual task training) | Experimental | Other: Dual task trainingGroup B will receive cognitive motor dual task training for 12 weeks (4 times per week) for 60 minutes. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Both male and female patients.
- Age limit for patients will be above 65.
- Patients with Mild and moderate cognitive impairment patients MoCA 13-25.
- Patients with Berge balance scale value 41-50.
- Patients who give consent to participate in study and undergo relevant test.
Key exclusion criteria (5 listed)
- Patients with any musculoskeletal disorder in which these exercises are contraindicated.
- Patients using any walking aids.
- Patients with hearing impairment.
- Patients with other neurological conditions with limit the patient participation in planned exercise like stroke, Parkinson's.
- Patients with diagnosed psychiatric disorder or taking medication that affect cognitive function within 24 hours.
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 |
|---|---|---|
| Lee Silverman treatment bigHalf of the treatment sessions consist of standardized multidirectional whole-body movements performed with maximal amplitude of reaching and stepping. The second half is designed to address individual deficits in movement that occur in activities of daily living. Dosage: 4 consecutive days a week for 12 weeks (16 sessions in one month) for 60 minutes Repetitions: minimum 8-16 repetitions/task | Other | Group A (LSVT BIG) |
| Dual task trainingGroup B will receive cognitive motor dual task training for 60 minutes, 4 times a week for 12 weeks. The intervention include both motor and cognitive components. | Other | Group B ( Dual task training) |
Primary outcome
Mini BESTest
Time frame: 4th week
It is a short form of the BESTest which include 14 items only. The Mini-BESTest includes asses aspects of dynamic balance control also and control while walking and performing a cognitive task.
MoCA (Montreal Cognitive Assessment (For Cognition)
Time frame: 4th week
The Montreal Cognitive Assessment (MoCA) is cognitive screening tool which include 30 points. It measures visuospatial, short term memory, orientation, language, executive functioning along with attention/concentration/working memory.
Stroop test
Time frame: 4th week
The Stroop task is one of the most widely used measures of cognitive functioning. The Stroop test requires participants to name the color in which a presented word is printed. Numerous studies have shown that participants need more time to name ink colors of incongruent words than to name ink colors of control patches.
Time up and go test
Time frame: 4th week
Timed Up and Go (TUG) have been used in clinical settings as a measure of physical performance in older adults with and without cognitive dysfunction. This test requires people to stand up from a chair, walk 3 m, turn around, walk back to the chair, and sit down again.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 29851819Park MO, Lee SH. Effects of cognitive-motor dual-task training combined with auditory motor synchronization training on cognitive functioning in individuals with chronic stroke: A pilot randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(22):e10910. doi: 10.1097/MD.0000000000010910.
- Background: PubMed 24557655Janssens J, Malfroid K, Nyffeler T, Bohlhalter S, Vanbellingen T. Application of LSVT BIG intervention to address gait, balance, bed mobility, and dexterity in people with Parkinson disease: a case series. Phys Ther. 2014 Jul;94(7):1014-23. doi: 10.2522/ptj.20130232. Epub 2014 Feb 20.
- Background: PubMed 11175678Morris S, Morris ME, Iansek R. Reliability of measurements obtained with the Timed "Up & Go" test in people with Parkinson disease. Phys Ther. 2001 Feb;81(2):810-8. doi: 10.1093/ptj/81.2.810.
- Background: PubMed 36035074Daniel B, Agenagnew L, Workicho A, Abera M. Psychometric Properties of the Montreal Cognitive Assessment (MoCA) to Detect Major Neurocognitive Disorder Among Older People in Ethiopia: A Validation Study. Neuropsychiatr Dis Treat. 2022 Aug 22;18:1789-1798. doi: 10.2147/NDT.S377430. eCollection 2022.
- Background: PubMed 27729692Das S, Mitra K, Mandal M. Sample size calculation: Basic principles. Indian J Anaesth. 2016 Sep;60(9):652-656. doi: 10.4103/0019-5049.190621.
- Background: PubMed 37297684Kim JH, Park JH. Does Cognitive-Physical Dual-Task Training Have Better Clinical Outcomes than Cognitive Single-Task Training Does? A Single-Blind, Randomized Controlled Trial. Healthcare (Basel). 2023 May 25;11(11):1544. doi: 10.3390/healthcare11111544.
- Background: PubMed 35679826Parial LL, Kor PPK, Sumile EF, Leung AYM. Dual-Task Zumba Gold for Improving the Cognition of People With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial. Gerontologist. 2023 Aug 24;63(7):1248-1261. doi: 10.1093/geront/gnac081.
- Background: PubMed 38267603Kaya Aytutuldu G, Ersoz Huseyinsinoglu B, Karagoz Sakalli N, Sen A, Yeldan I. LSVT(R) BIG versus progressive structured mobility training through synchronous telerehabilitation in Parkinson's disease: A randomized controlled trial. Neurol Sci. 2024 Jul;45(7):3163-3172. doi: 10.1007/s10072-024-07322-0. Epub 2024 Jan 25.
- Background: PubMed 32652957Peterka M, Odorfer T, Schwab M, Volkmann J, Zeller D. LSVT-BIG therapy in Parkinson's disease: physiological evidence for proprioceptive recalibration. BMC Neurol. 2020 Jul 11;20(1):276. doi: 10.1186/s12883-020-01858-2.
- Background: PubMed 34004389Huang X, Zhao X, Li B, Cai Y, Zhang S, Wan Q, Yu F. Comparative efficacy of various exercise interventions on cognitive function in patients with mild cognitive impairment or dementia: A systematic review and network meta-analysis. J Sport Health Sci. 2022 Mar;11(2):212-223. doi: 10.1016/j.jshs.2021.05.003. Epub 2021 May 16.
- Background: PubMed 30712518Farhang M, Miranda-Castillo C, Rubio M, Furtado G. Impact of mind-body interventions in older adults with mild cognitive impairment: a systematic review. Int Psychogeriatr. 2019 May;31(5):643-666. doi: 10.1017/S1041610218002302. Epub 2019 Feb 4.
- Background: PubMed 31299921Kim O, Pang Y, Kim JH. The effectiveness of virtual reality for people with mild cognitive impairment or dementia: a meta-analysis. BMC Psychiatry. 2019 Jul 12;19(1):219. doi: 10.1186/s12888-019-2180-x.
- 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.
Arooba Saeed, 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 testing Lee Silverman treatment big and Dual task training in people with Cognitive Impairment and Balance Changes, 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 5 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arooba Saeed, phD (03344399403, aruba.saeed@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini BESTest (time frame: 4th week). The study lists 4 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 NCT06927362, which also lists 13 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 22 Aug 2025.