NCT06303050

Brief Summary

The objective of this study to determine the effect of mental imagery and task oriented training on Kinesiophobia in stroke patients. And to determine the association of Kinesiophobia with gait and balance in stroke patients. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. The experimental group will receive 20 minutes of MI training followed by 25 minutes of TOT for a total of 45 minutes, 5 days per week for 6 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2024

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

March 4, 2024

Last Update Submit

December 29, 2025

Conditions

Keywords

Mental ImageryKinesiophobiaTask oriented training

Outcome Measures

Primary Outcomes (5)

  • Berg And Balance scale

    changes from the baseline, Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL \_\_/56

    6 weeks

  • Tempa scale for kinesiophobia

    It consists of 17 items asking patients to rate their responses to statements related to fear of movement and re injury. It has been widely used among patients with various types of pain and has been translated into several languages. The TSK-17 is a useful tool for assessing kinesiophobia and can aid clinicians in developing appropriate treatment plans for patients who may have fear of movement due to pain or injury (20). The TSK exhibit high level of in- ternal consistency across all items and is positively associated with related measures of fear avoidance, pain catastrophizing, pain related disability. In the Finnish version of TSK the test-retest reliability

    6 weeks

  • Ten-meter walk test

    The 10- meter walk test is a commonly used tool to measure gait and walking speed in individuals with mobility impairments, including post-stroke individuals. During the test subjects are instructed to walk along a 10-meter walkway at their preferred walking speed, with or without a customary walking device, without any break to the end point. The time taken to recover the middle 4 meters of the walkway is recorded to obtain a rhythmic phase of walking speed. This ensures that the acceleration and deceleration phases of walking are excluded from the measurement of walking speed. Then the time required over three trials is converted to walking speed by dividing the distance (6 meters) by the time taken in seconds to complete the walk.

    6 weeks

  • Dynamic gate index

    The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24.

    6 weeks

  • Time Up and Go Test

    Timed up and go test is used for the assessment of falls risk among the elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time is taken by an individual to stand up from a standard armchair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: \<10 seconds = normal \<20 seconds = good mobility, can go out alone, mobile without a gait aid \<30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate a high risk of falls.

    6 weeks

Study Arms (2)

Mental Imagery with task Oriented training group

EXPERIMENTAL

Participants will perform warm-up exercise for 5 minutes to prepare the body for functional task and to improve overall performance.

Other: Mental Imagery with task Oriented training group

Task Oriented training group

ACTIVE COMPARATOR

Task oriented training In standing, forward stepping and sideward stepping, reaching in standing, Transition from sit to stand, Walk then back to sit, Walk with even steps, Walk with carrying objects.

Other: Task Oriented training group

Interventions

Study will be conducted after the approval of Ethical review board. After the initial evaluation will be done on participants underlying eligibility criteria. The control group will receive the Task oriented training for 25-30 minutes, 05 days a week for 06 weeks consisting of Warm up Period, Task oriented training In standing, forward stepping and sideward stepping, reaching in standing, Transition from sit to stand, Walk then back to sit, Walk with even steps, Walk with carrying objects.

Task Oriented training group

Study will be conducted after the approval of Ethical review board. After the initial evaluation will be done on participants underlying eligibility criteria. The experimental group will receive 20 minutes of MI training followed by 25 minutes of TOT for a total of 45 minutes, 5 days per week for 6 weeks. During each 45 minutes of session, the participants will perform warm-up exercise for 5 minutes to prepare the body for functional task and to improve overall performance. Regular breaks will give to the participants to avoid overexertion and fatigue during 45 minutes of continues practice. The 2 minutes rest period will provide to the partici-pants during each practice session

Mental Imagery with task Oriented training group

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hemiplegic stroke patients
  • Age above 45
  • Both genders
  • Patients having score \>17 on Tempa Scale of Kinesiophobia
  • Patients of score \>21 on Berg Balance Scale

You may not qualify if:

  • Communication deficits and unable to follow instructions
  • A history of serious or unstable cardiac condition
  • Severe musculoskeletal problem and unable to stand or walk
  • History of other neurological diseases or unilateral neglect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Medical University

Peshawar, KPK, 2500, Pakistan

Location

MeSH Terms

Conditions

Myocardial InfarctionKinesiophobia

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Nadia Azhar, MS-NMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

December 7, 2023

Primary Completion

June 7, 2024

Study Completion

June 7, 2024

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations