LSVT Big and Dual Task Training in Cognitive Impaired Patients

NCT ID: NCT06927362

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-10

Study Completion Date

2025-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Impairment Balance Changes Cognition Disorders in Old Age Functional Mobility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A (LSVT BIG)

Group A will receive SLVT BIG intervention for 12 week (4 times per week) for 60 minutes

Group Type EXPERIMENTAL

Lee Silverman treatment big

Intervention Type OTHER

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

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 Type EXPERIMENTAL

Dual task training

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lee Silverman treatment big

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

Intervention Type OTHER

Dual task training

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arooba Saeed, phD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Iqra Medical Complex and Irtiqa Fitness Club

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Arooba Saeed, phD

Role: CONTACT

03344399403

Rabia Aslam, MS(NMPT)

Role: CONTACT

03233337849

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aruba Saeed

Role: primary

344399403

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29851819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24557655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11175678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36035074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27729692 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37297684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35679826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38267603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32652957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34004389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30712518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31299921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31835502 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/0258 Rabia Aslam

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Spacing Lidcombe Program Clinic Visits
NCT00680303 UNKNOWN PHASE2