NCT05857657

Brief Summary

The aim of this research is to find the immediate effects of propriocepticve neuromuscular facilitation with lower leg kinesiotaping on ankle dorsiflexion, gait and functional mobility in patients with chronic stroke. It will be a randomized clinical trial in which participants will be selected through non probability convenience sampling. Patients aged range from 40 to 70 years, both gender, diagnosed with hemiplegia due to hemorrhagic or ischemic stroke for more than 6 months, with insufficient ankle dorsi flexion less than 8 degree will be included in this study whereas patients with neurological problems other than stroke that would interfere with gait and balance control and with limbs affected bilaterally will be excluded from study. Participant will be randomly allocated into three groups (A,B and C). Group A will receive only ankle kinesiotaping that will be applied for 30 minutes for one session. Group B will receive proprioceptive neuromuscular facilitation hold-relax technique in flexion-adduction-external rotation pattern, 15-20 repetitions that will be applied in lying position for 10-15 minutes for one session. Group C will receive both proprioceptive neuromuscular facilitation hold-relax technique with ankle kinesiotaping. Posttest measurement will be taken after 30 minutes of one session of treatment using Time up and GO (TUG) test, dynamic gait index, barthel index and Motor Assessment Scale . Data will be analyzed by SPSS version 21

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 Mar 2023

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

Study Start

First participant enrolled

March 5, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

March 31, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

Stroke, ankle dorsiflexion, PNF

Outcome Measures

Primary Outcomes (4)

  • Time up and go test

    To determine fall risk and measure the progress of balance, sit to stand and walking. Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.The test is a reliable and valid test for quantifying functional mobility. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention.

    Baseline and after 1 hour

  • Barthel Index

    The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently.Total score of 100 with proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.

    Baseline and after 1 hour

  • Motor Assessment scale

    The Motor Assessment Scale (MAS) is a performance-based scale used to assess level of impairment and everyday motor function in patients with stroke. The 9 items assessment evaluates 5 Mobility and 3 Upper Limb activities, and 1 the severity of involuntary movements UMN lesions (clonus). Each of the items is scored on a 7 point hierarchical difficulty scale. A score of 0 indicates the individual is unable to complete any of the tasks within a category. A score of 6 implies the individual is not only able to perform the most difficult task, but also all lower scored tasks

    Baseline and after 1 hour

  • Dynamic gait index

    The DGI assesses individual's ability to modify balance while walking in the presence of external demands. • The Dynamic Gait Index (DGI) was developed as a clinical tool to assess gait, balance and fall risk. It evaluates not only the. usual steady-state walking, but also walking during more challenging tasks. 8 functional walking tests are performed by the subject and marked out of three according to the lowest category which applies. 24 is the total individual score possible. Scores of 19 or less have been related to increase incidence of falls. \[Time Frame: Both pre intervention and post intervention of only one treatment session.\]

    Baseline and after 1 hour

Study Arms (3)

lower leg kinesiotaping

EXPERIMENTAL

Kinesiotaping will be applied on tibialis anterior for 30 minutes for one session

Other: : lower leg kinesiotaping

propriocepticve neuromuscular facilitation

EXPERIMENTAL

:Proprioceptive neuromuscular facilitation hold relax technique will be applied to ankle with 15-30 repititions on affected side for one session

Other: propriocepticve neuromuscular facilitation

propriocepticve neuromuscular facilitation with lower leg kinesiotaping

ACTIVE COMPARATOR

Kinesiotaping will be applied on tibialis anterior for 30 minutes with proprioceptive neuromuscular facilitation hold relax technique will be applied to ankle with 15-30 repititions on affected side for one session

Other: propriocepticve neuromuscular facilitation with lower leg kinesiotaping

Interventions

Kinesiotaping will be applied on tibialis anterior for 30 minutes for one session

lower leg kinesiotaping

:Proprioceptive neuromuscular facilitation hold relax technique will be applied to ankle with 15-30 repititions on affected side for one session

propriocepticve neuromuscular facilitation

Kinesiotaping will be applied on tibialis anterior for 30 minutes with proprioceptive neuromuscular facilitation hold relax technique will be applied to ankle with 15-30 repititions on affected side for one session

propriocepticve neuromuscular facilitation with lower leg kinesiotaping

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with hemiplegia due to hemorrhagic or ischemic stroke for more than 6 months
  • Able to walk independently for over 10 m without assistive device
  • Ability to comprehend simple instructions(Mini-Mental State Examination (MMSE) score above 24)
  • Insufficient ankle dorsiflexion during the swing phase of the gait cycle and less than 8 degree of ankle dorsiflexion range of motion on the affected side during gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Wall HK, Beagan BM, O'Neill J, Foell KM, Boddie-Willis CL. Addressing stroke signs and symptoms through public education: the Stroke Heroes Act FAST campaign. Prev Chronic Dis. 2008 Apr;5(2):A49. Epub 2008 Mar 15.

    PMID: 18341784BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Fatima Noor

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 31, 2023

First Posted

May 12, 2023

Study Start

March 5, 2023

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations