LSVT Big and Dual Task Training in Cognitive Impaired Patients

NCT06927362 | Recruiting DMC

• 1 other identifier: REC/0258 Rabia Aslam
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Impairment; Balance Changes; Cognition Disorders in Old Age; Functional Mobility

Keywords

LSVT big; dual task training; cognitive impaired patients; cognition

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  4th week

Study Arms (2)

Group A (LSVT BIG)

EXPERIMENTAL

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

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.

Other: Dual task training

Interventions

Lee Silverman treatment big 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 A (LSVT BIG)

Dual task training 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.

Group B ( Dual task training)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Iqra Medical Complex and Irtiqa Fitness Club

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

Related Publications (13)

• 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.

  PMID: 29851819 BACKGROUND

• 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.

  PMID: 24557655 BACKGROUND

• 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.

  PMID: 11175678 BACKGROUND

• 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.

  PMID: 36035074 BACKGROUND

• 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.

  PMID: 27729692 BACKGROUND

• 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.

  PMID: 37297684 BACKGROUND

• 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.

  PMID: 35679826 BACKGROUND

• 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.

  PMID: 38267603 BACKGROUND

• 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.

  PMID: 32652957 BACKGROUND

• 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.

  PMID: 34004389 BACKGROUND

• 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.

  PMID: 30712518 BACKGROUND

• 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.

  PMID: 31299921 BACKGROUND

• 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.

  PMID: 31835502 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Arooba Saeed, phD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arooba Saeed, phD

CONTACT

03344399403; aruba.saeed@riphah.edu.pk

Rabia Aslam, MS(NMPT)

CONTACT

03233337849; drrabiaaslamdpt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: April 10, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)