NCT04086004

Brief Summary

The importance of potent rehabilitation with dual task balance and gait training is improving and also there have been divergent opinions about the effectiveness of Motor Imagery on balance and gait function. Dual tasking has also proved beneficial results on stroke patients. Mental stimulation with task performance is a new intervention.. So the purpose of my study is to investigate the combination of Motor Imagery Practice and dual task rehabilitative training on balance and gait targeting the population of post stroke patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 4, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

September 4, 2019

Last Update Submit

October 13, 2020

Conditions

Stroke

Keywords

Motor Imagery practiceStrokeDual task training

Outcome Measures

Primary Outcomes (3)

  • Berg balance scale

    The Berg balance scale (BBS) is used to assess the participant's ability to retain stability. The BBS is a widely used test for the assessment of elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points. The scale has been shown to be reliable and valid in stroke patients. A cut-off score of 45 points is used for fall prediction. The BBS involves 14 tasks; a total score of 56. Equipment required for this test were a stop watch or watch with a second's hand and a ruler or other indicator of 2, 5, and 10 inches. Excellent reliability (ICC range, 0.98-0.99) has been found in individuals with stroke survivors for BBS

    Change from Baseline balance to 8 Weeks

  • Timed Up and Go test

    The Timed Up and Go (TUG) test was designed for the evaluation of balance and Measures mobility in people who are able to walk on their own (assistive device permitted) to find out the risk of fall . The subjects will be required to stand up from a chair, walk 3 m, turn around, return to the chair, and sit down. The time taken to complete this task will be measured. The test will be informed three times. The time required to complete this task will be measured from a stopwatch. The average values from 3 trials, with 1-min rest between each trial, were used for data analysis. This test has excellent reliability (ICC \> 0.95) with stroke survivors

    Change from Baseline balance and mobility to 8 Weeks

  • Functional reach Test:

    The patient is instructed to stand alongside a wall, however not contacting, a wall and position the arm that is nearer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the beginning position at the third metacarpal head on the measuring stick. Teach the patient to "Reach the extent that you can forward without taking a step." The area of the third metacarpal is recorded before and after a maximal forward reach. The mean score of three successful trials was calculated. Test-retest reliability of FR is high (interclass correlation coefficient (ICC) = 0.92) as interrater reliability is (ICC = 0.98)

    Change from Baseline balance to 8 Weeks

Secondary Outcomes (1)

  • Fugl Meyer Scale (FMS)

    Change from Baseline to 8 Weeks

Study Arms (2)

Group I Experimental Motor Imagery

EXPERIMENTAL

Motor imagery practice

Other: Group I Experimental Motor Imagery

Group II Dual Task Training

EXPERIMENTAL

Dual-task balance training

Other: Dual task training

Interventions

Group I Experimental Motor ImageryOTHER

The experimental group will receive dual task balance training for 30 minutes/day with additional mental imagery for 10 minutes/day, three days/week, for a period of eight weeks

Also known as: Group II Experimental Dual Task Training
Group I Experimental Motor Imagery
Dual task trainingOTHER

group will receive dual task balance training for 40 minutes for three days/ week for eight weeks

Group II Dual Task Training

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Modified Rankin scale disability level 2-3
  • Sub acute and chronic stroke patients.
  • Ability to walk independently over ground for at least 10 m with or without use of an assistive device
  • absence of any cognitive impairment
  • No significant body or visual spatial hemi-neglect,
  • Good ability for imagery functioning (a score of 32 or higher on the revision of Movement Imagery Questionnaire)

You may not qualify if:

  • The patient will be excluded if he/she reported serious visual or somatosensory, orthopedic impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Islamabad, Punjab Province, 46000, Pakistan

Location

Related Publications (5)

  • Walker C, Brouwer BJ, Culham EG. Use of visual feedback in retraining balance following acute stroke. Phys Ther. 2000 Sep;80(9):886-95.

    PMID: 10960936BACKGROUND

  • Khealani BA, Hameed B, Mapari UU. Stroke in Pakistan. J Pak Med Assoc. 2008 Jul;58(7):400-3.

    PMID: 18988415BACKGROUND

  • Kim SS, Lee HJ, You YY. Effects of ankle strengthening exercises combined with motor imagery training on the timed up and go test score and weight bearing ratio in stroke patients. J Phys Ther Sci. 2015 Jul;27(7):2303-5. doi: 10.1589/jpts.27.2303. Epub 2015 Jul 22.

    PMID: 26311971BACKGROUND

  • Kenyon LK, Blackinton MT. Applying motor-control theory to physical therapy practice: a case report. Physiother Can. 2011 Summer;63(3):345-54. doi: 10.3138/ptc.2010-06. Epub 2011 Aug 10.

    PMID: 22654241BACKGROUND

  • Melzer I, Goldring M, Melzer Y, Green E, Tzedek I. Voluntary stepping behavior under single- and dual-task conditions in chronic stroke survivors: A comparison between the involved and uninvolved legs. J Electromyogr Kinesiol. 2010 Dec;20(6):1082-7. doi: 10.1016/j.jelekin.2010.07.001. Epub 2010 Aug 2.

    PMID: 20675152BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Misbah Ghous, MsNMPT

    Riphah International University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 4, 2019

First Posted

September 11, 2019

Study Start

April 1, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)