NCT03822923

Brief Summary

Data will be collected from 40 patients with hemiplegia, caused by stroke from DHQ hospital Jhelum. its an RCT Neurodynamics with conventional treatment to experimental group and conventional treatment alone to control group will be applied for 6 weeks. Simple random sampling will be done and randomization will be done through tossing a coin. Intervention wil be applied and assesment will be done through fugl-meyer upper extremity scale, Modified Aashwarth scale,goniometry and action research arm test at zero, 3rd and 6th week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2019

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

January 23, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

January 28, 2019

Last Update Submit

September 5, 2019

Conditions

Stroke

Keywords

NeurodynamicsSpasticityStroke

Outcome Measures

Primary Outcomes (1)

  • Modified Ashwarth Scale

    Effects of neurodynamics to reduce spasticity in uppper extremity will be assesed through Modified Ashwarth Scale changes from Baseline. Modified Ashwarth Scale is a specific scale to asses spasticity. Scoring is done from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).

    6th weeks

Secondary Outcomes (5)

  • Range of motion Shoulder Joint (Flexion, Extension, abduction, internal rotation, external rotation )

    6th weeks

  • Fugl Meyer upper extremity scale

    6th weeks

  • Action research arm test (ARAT)

    6th week

  • Range of motion of elbow joint ( flexion, extension, forearm Supination , Pronation)

    6th week

  • Range of motion of Wrist joint (flexion, extension , ulnar deviation , thumb abduction )

    6th Week

Study Arms (2)

Experimental group

EXPERIMENTAL

Neurodynamics (Dynamic Neural Mobilization) with conventional treatment (stretching, AROM) will be applied.

Other: Experimental group

control group

ACTIVE COMPARATOR

Conventional treatment (stretching, AROM) will be applied

Other: Control group

Interventions

Experimental groupOTHER

Neurodynamics with conventional treatment. Intervention will be applied for 6 weeks (10 reps per set, 1 set per day, 3 days per week) for 30 minutes

Experimental group
Control groupOTHER

Conventional treatment

control group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Modified Ashworth scale (MAS) of 1 to 3, chronic cases (6 -12 months)

You may not qualify if:

  • Modified Ashworth scale (MAS) 0 and 4, painfull upper extremity, orthopedic problem (e.g fracture)
  • In upper extremity, UMNL other than stroke,
  • Any signs of inflammation, infection or malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (5)

  • Santana AL. Efeito da mobilização neural na amplitude articular do ombro em pacientes acometidos com acidente vascular encefálico. Revista Inspirar: movimento & saúde. 2013; (5)6:7-10.

    BACKGROUND

  • Jeong Kang et al, The Effects of Rhythmic Neurodynamic on the Upper Extremity Nerve Conduction Velocity and the Function for Stroke Patients, JKPT 2017, Volume 29 No. 4.

    BACKGROUND

  • Alan Carlos Nery dos Santos et al, The effects of neural mobilization as a therapeutic option in the treatment of stroke, MTP and Rehab journal 2017, ISSN 2236-5435.

    BACKGROUND

  • Villafane JH, Silva GB, Chiarotto A, Ragusa OL. Botulinum toxin type A combined with neurodynamic mobilization for upper limb spasticity after stroke: a case report. J Chiropr Med. 2012 Sep;11(3):186-91. doi: 10.1016/j.jcm.2012.05.009.

    PMID: 23449315BACKGROUND

  • Raid Saleem Al Baradie et al, The effects of Neurodynamics and mobilization in Stroke Rehabilitation- a Systematic Review, Majmaah Journal of Health Sciences 2017, Vol.5, issue 2.

    BACKGROUND

MeSH Terms

Conditions

StrokeMuscle Spasticity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Mirza Obaid Baig, MS-NMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 30, 2019

Study Start

January 23, 2019

Primary Completion

July 20, 2019

Study Completion

July 31, 2019

Last Updated

September 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)