NCT06696911

Brief Summary

This research explores the combined effects of motor imagery and core stability exercises on trunk control, balance, and sleep quality in stroke recovery, addressing Pakistan's unique healthcare challenges. By enhancing neuroplasticity, core strength, and physical function, these interventions aim to improve mobility, independence, and overall quality of life for stroke survivors, while addressing common sleep disturbances.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 18, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

StrokeCore Stability ExercisesMotor ImageryBalance

Outcome Measures

Primary Outcomes (1)

  • • Berg Balance Scale ( BBS)

    The Berg Balance Scale evaluates changes in static balance over time .Each item is a 5-point ordinal scale ranging from 0 to 4, with 0 indicating lowest level of function and 4 indicating highest level of function. It has 14 items and the maximum score is 56, higher the score, the better the balance function, while the lower the score, the worse the balance function.

    12th week

Study Arms (2)

Core Stability Exercises and Motor Imagery

EXPERIMENTAL

Core stability exercises are voluntary movements designed to maintain the balance, functional mobility, gait, fear of falling, and anticipatory postural adjustment among stroke survivors. Motor perception or motor imagery (MI) is a mental task that involves visualizing a physical movement without actually doing the action

Procedure: Core stability ExercisesProcedure: Motor Imagery

Core Stability Exercises

ACTIVE COMPARATOR

Core stability exercises are voluntary movements designed to maintain the balance, functional mobility, gait, fear of falling, and anticipatory postural adjustment among stroke survivors.

Procedure: Motor Imagery

Interventions

The exercises have been divided into three difficulty categories based on the level of difficulty. Level I: When the patients were unable to sit independently, level I core stability therapy was administered. First-level exercises were done in a supine position on a plinth. The workout program mostly included side bridging movements, leg crosses, one-leg curl-ups, and straight and diagonal reaching activities. Patients can move to level once they can sit on a plinth edge unsupported for one minute while flexing their knees and hips to 90 degrees. Level II: Exercises included straight-arm curl-ups, diagonal-arm curl-ups, and arm curl-ups with the arms crossed. The patient will go to stage three once they can sit on an unstable surface for thirty seconds. Level III: Using a physio ball, the exercises were done while seated. The exercises performed with the ball consisted push-ups, bird dog, side Bridge, abdominal curl-ups, and bridge movements

Core Stability Exercises and Motor Imagery
Motor ImageryPROCEDURE

The motor imagery program will be performed in three steps. STEP 1 Subjects will be instructed to watch the video provided and recorded by investigator. Two types of videos will be available to watch. One recording normal movements and the other film will contain recording the patient movements. Patient will be asked to watch the video and analyze the differences. STEP 2 In next step participants will be asked to close the eyes to focus and then to imagine how they are doing task they had previously observed 10 times. STEP 3 Participants will be than instructed to carry out the task in verbal commands given whenever necessary. During the recall process components of movement deviating from normal will be emphasized. The difficulty level of activities and the analysis of movement components will be increased gradually according to the patient's capacity.

Core Stability ExercisesCore Stability Exercises and Motor Imagery

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with stroke (ischemic or hemorrhagic) within the last 6 months to 2 years.
  • Hemiplegic Patient
  • Having MMSE score ≥ 24
  • Experiencing balance impairments on BBS 21-40
  • Having sleep disturbances on PSQI 15-21.
  • Willing to provide informed consent.

You may not qualify if:

  • Other neurological or musculoskeletal conditions affecting balance.
  • Severe cardiovascular or respiratory conditions contraindicating exercise.
  • Participation in another clinical trial within the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Well Versed Physio Clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (21)

  • Kashif M, Ahmad A, Bandpei MAM, Gilani SA, Hanif A, Iram H. Combined effects of virtual reality techniques and motor imagery on balance, motor function and activities of daily living in patients with Parkinson's disease: a randomized controlled trial. BMC Geriatr. 2022 Apr 30;22(1):381. doi: 10.1186/s12877-022-03035-1.

    PMID: 35488213BACKGROUND
  • Niu S, Liu X, Wu Q, Ma J, Wu S, Zeng L, Shi Y. Sleep Quality and Cognitive Function after Stroke: The Mediating Roles of Depression and Anxiety Symptoms. Int J Environ Res Public Health. 2023 Jan 29;20(3):2410. doi: 10.3390/ijerph20032410.

    PMID: 36767777BACKGROUND
  • Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.

    PMID: 15137564BACKGROUND
  • Miyata K, Tamura S, Kobayashi S, Takeda R, Iwamoto H. Berg Balance Scale is a Valid Measure for Plan Interventions and for Assessing Changes in Postural Balance in Patients with Stroke. J Rehabil Med. 2022 Dec 9;54:jrm00359. doi: 10.2340/jrm.v54.4443.

    PMID: 36484715BACKGROUND
  • Park M, Seok H, Kim SH, Noh K, Lee SY. Comparison Between Neuromuscular Electrical Stimulation to Abdominal and Back Muscles on Postural Balance in Post-stroke Hemiplegic Patients. Ann Rehabil Med. 2018 Oct;42(5):652-659. doi: 10.5535/arm.2018.42.5.652. Epub 2018 Oct 31.

    PMID: 30404414BACKGROUND
  • Liu W, Cheng X, Rao J, Yu J, Lin Z, Wang Y, Wang L, Li D, Liu L, Gao R. Motor imagery therapy improved upper limb motor function in stroke patients with hemiplegia by increasing functional connectivity of sensorimotor and cognitive networks. Front Hum Neurosci. 2024 Feb 19;18:1295859. doi: 10.3389/fnhum.2024.1295859. eCollection 2024.

    PMID: 38439937BACKGROUND
  • Binks JA, Emerson JR, Scott MW, Wilson C, van Schaik P, Eaves DL. Enhancing upper-limb neurorehabilitation in chronic stroke survivors using combined action observation and motor imagery therapy. Front Neurol. 2023 Mar 2;14:1097422. doi: 10.3389/fneur.2023.1097422. eCollection 2023.

    PMID: 36937513BACKGROUND
  • Karthikbabu S, Ganesan S, Ellajosyula R, Solomon JM, Kedambadi RC, Mahabala C. Core Stability Exercises Yield Multiple Benefits for Patients With Chronic Stroke: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Apr 1;101(4):314-323. doi: 10.1097/PHM.0000000000001794.

    PMID: 34001840BACKGROUND
  • Chen X, Gan Z, Tian W, Lv Y. Effects of rehabilitation training of core muscle stability on stroke patients with hemiplegia. Pak J Med Sci. 2020 Mar-Apr;36(3):461-466. doi: 10.12669/pjms.36.3.1466.

    PMID: 32292453BACKGROUND
  • Cabrera-Martos I, Ortiz-Rubio A, Torres-Sanchez I, Lopez-Lopez L, Jarrar M, Valenza MC. The Effectiveness of Core Exercising for Postural Control in Patients with Stroke: A Systematic Review and Meta-Analysis. PM R. 2020 Nov;12(11):1157-1168. doi: 10.1002/pmrj.12330. Epub 2020 Feb 17.

    PMID: 31950672BACKGROUND
  • Lee SA, Cha HG. The effect of motor imagery and mirror therapy on upper extremity function according to the level of cognition in stroke patients. Int J Rehabil Res. 2019 Dec;42(4):330-336. doi: 10.1097/MRR.0000000000000366.

    PMID: 31425348BACKGROUND
  • Ma ZZ, Wu JJ, Hua XY, Zheng MX, Xing XX, Ma J, Li SS, Shan CL, Xu JG. Brain Function and Upper Limb Deficit in Stroke With Motor Execution and Imagery: A Cross-Sectional Functional Magnetic Resonance Imaging Study. Front Neurosci. 2022 May 19;16:806406. doi: 10.3389/fnins.2022.806406. eCollection 2022.

    PMID: 35663563BACKGROUND
  • Jeffers MS, Pittman AC, Kendzerska T, Corbett D, Hayward KS, Chen Y. Self-reported sleep disturbances among people who have had a stroke: a cross-sectional analysis. CMAJ. 2023 Mar 14;195(10):E354-E362. doi: 10.1503/cmaj.221063.

    PMID: 36918185BACKGROUND
  • Iddagoda MT, Inderjeeth CA, Chan K, Raymond WD. Post-stroke sleep disturbances and rehabilitation outcomes: a prospective cohort study. Intern Med J. 2020 Feb;50(2):208-213. doi: 10.1111/imj.14372.

    PMID: 31111660BACKGROUND
  • Zhang Y, Wang C, Yang J, Qiao L, Xu Y, Yu L, Wang J, Ni W, Wang Y, Yao Y, Yong Z, Ding S. Comparing the Effects of Short-Term Liuzijue Exercise and Core Stability Training on Balance Function in Patients Recovering From Stroke: A Pilot Randomized Controlled Trial. Front Neurol. 2022 Feb 10;13:748754. doi: 10.3389/fneur.2022.748754. eCollection 2022.

    PMID: 35242094BACKGROUND
  • Khallaf ME. Effect of Task-Specific Training on Trunk Control and Balance in Patients with Subacute Stroke. Neurol Res Int. 2020 Nov 17;2020:5090193. doi: 10.1155/2020/5090193. eCollection 2020.

    PMID: 33294224BACKGROUND
  • Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, Hernandez-Valino M, Urrutia Cuchi G. The effect of additional core stability exercises on improving dynamic sitting balance and trunk control for subacute stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1024-1033. doi: 10.1177/0269215515609414. Epub 2015 Oct 8.

    PMID: 26451007BACKGROUND
  • Sonmez I, Karasel S. Poor Sleep Quality I Related to Impaired Functional Status Following Stroke. J Stroke Cerebrovasc Dis. 2019 Nov;28(11):104349. doi: 10.1016/j.jstrokecerebrovasdis.2019.104349. Epub 2019 Sep 3.

    PMID: 31492629BACKGROUND
  • Monteiro KB, Cardoso MDS, Cabral VRDC, Santos AOBD, Silva PSD, Castro JBP, Vale RGS. Effects of Motor Imagery as a Complementary Resource on the Rehabilitation of Stroke Patients: A Meta-Analysis of Randomized Trials. J Stroke Cerebrovasc Dis. 2021 Aug;30(8):105876. doi: 10.1016/j.jstrokecerebrovasdis.2021.105876. Epub 2021 May 25.

    PMID: 34049014BACKGROUND
  • Khazaei S, Ayubi E, Khazaei M, Khazaei M, Afrookhteh G. Sleep Quality and Related Determinants among Stroke Patients: A Cross-Sectional Study. Iran J Psychiatry. 2022 Jan;17(1):84-90. doi: 10.18502/ijps.v17i1.8052.

    PMID: 35480131BACKGROUND
  • Xiao M, Huang G, Feng L, Luan X, Wang Q, Ren W, Chen S, He J. Impact of sleep quality on post-stroke anxiety in stroke patients. Brain Behav. 2020 Dec;10(12):e01716. doi: 10.1002/brb3.1716. Epub 2020 Nov 3.

    PMID: 33140545BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aruba Saeed, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 20, 2024

Study Start

September 1, 2024

Primary Completion

February 28, 2025

Study Completion

May 30, 2025

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations