NCT02937311

Brief Summary

This study aimed to compare the effects of kinesiotaping, neuromuscular electric stimulation (NMES), and neuromuscular training on pain, and motor activity and function in patients with upper extremity hemiplegia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

October 14, 2016

Last Update Submit

February 8, 2019

Conditions

Keywords

Taping, strokerehabilitationshoulder painelectrical stimulation

Outcome Measures

Primary Outcomes (1)

  • Motor Activity Log-28,

    Motor Activity Log-28, is a clinical questionnaire developed to evaluate daily use of the hemiparetic arm outside of the treatment setting

    1 month

Secondary Outcomes (3)

  • Pain Visual Analogue Scale

    1 month

  • Brunnstrom Stages

    1 month

  • Fugl-Meyer Sensorimotor Assessment Scale (FM)

    1 month

Study Arms (3)

NMES group

EXPERIMENTAL

This group of patients received Neuromuscular Electrical Stimulation (NMES) and standardized physiotherapy and rehabilitation protocol

Other: NMESOther: Standardized Physiotherapy

Kinesiotape Group

EXPERIMENTAL

This group of patients received standardized physiotherapy and rehabilitation protocol and at the same time kinesiotape was applied to their affected shoulder

Other: KinesiotapeOther: Standardized Physiotherapy

Control

EXPERIMENTAL

This group of patients received only a standardized physiotherapy and rehabilitation protocol

Other: Standardized Physiotherapy

Interventions

NMESOTHER

Participants received NMES using a portable, page-sized battery-powered stimulation device, which delivered current-regulated, charge-balanced, asymmetrical biphasic pulses. The implementation was done on the deltoid and supraspinatus muscles

Also known as: Neuromuscular electric stimulation
NMES group

The deltoid and supraspinatus muscles were taped in this study to align the shoulder in correct position to facilitate the function and achieve preferred body alignment. For supraspinatus application, Y strip tape was applied from the muscle insertion at the greater tuberosity of the humerus to its origin at the supraspinatus fossa of the scapula while the muscle was in an overstretched position. No tension was applied to the tape. For deltoid application, Y-shaped tape was used by placing the anchor acromion process. The front tail was implemented in the extended arm position, while the back tail was implemented in the horizontal abducted arm position. Both tails ended below the deltoid tubercule of the humerus. No tension was applied during application.

Also known as: Taping
Kinesiotape Group

All participants received rehabilitation including Bobath neurophysiological approach. Bobath approach and other exercise programs were implemented early after the onset of the stroke to prevent immobility and soft tissue contracture and to alter the muscle tone to gain mobility. Through the exercise program and use of weight-bearing techniques, the therapist attempted to maintain and improve trunk and shoulder alignment to allow the functional use of the upper extremity.

Also known as: Physiotherapy and Rehabilitation
ControlKinesiotape GroupNMES group

Eligibility Criteria

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

You may qualify if:

  • had unilateral ischemic brain injury or intracerebral hemorrhage at least 1 week to maximum 24 months after the onset of single stroke without other diagnosed neurological or systematic deficits.
  • had enough cognition to be able to follow the training protocol as assessed by Mini Mental State Examination.
  • age 30-70 years.

You may not qualify if:

  • had a severe injury of the rotator cuff or a shoulder surgery history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HemiplegiaStrokeShoulder Pain

Interventions

Athletic TapePhysical Therapy ModalitiesRehabilitation

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArthralgiaJoint DiseasesMusculoskeletal DiseasesPain

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentTherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gul O KARABICAK, Phd

    Baskent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd PT

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 18, 2016

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

February 11, 2019

Record last verified: 2019-02