- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06927362
LSVT Big and Dual Task Training in Cognitive Impaired Patients
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arooba Saeed, phD
- Phone Number: 03344399403
- Email: aruba.saeed@riphah.edu.pk
Study Contact Backup
- Name: Rabia Aslam, MS(NMPT)
- Phone Number: 03233337849
- Email: drrabiaaslamdpt@gmail.com
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54660
- Recruiting
- Iqra Medical Complex and Irtiqa Fitness Club
-
Contact:
- Aruba Saeed
- Phone Number: 344399403
- Email: arubasaeedpt@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (LSVT BIG)
Group A will receive SLVT BIG intervention for 12 week (4 times per week) for 60 minutes
|
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 |
|
Experimental: Group B ( Dual task training)
Group B will receive cognitive motor dual task training for 12 weeks (4 times per week) for 60 minutes.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4th week
|
|
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.
|
4th week
|
|
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.
|
4th week
|
|
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.
|
4th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arooba Saeed, phD, Riphah International University
Publications and helpful links
General Publications
- Janssens 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.
- Kim 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.
- Morris 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.
- 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.
- Daniel 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.
- Das 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.
- Kim 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.
- Parial 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.
- Kaya 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.
- Peterka 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.
- Huang 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.
- Farhang 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.
- Veldkamp 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/0258 Rabia Aslam
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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