NCT03234426

Brief Summary

Following stroke, patients loses functions of the motor, sensory and higher brain cognitive faculties to various degrees which lead to diminished balance. It has been documented that hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight distribution, impaired weight-shifting ability and decreased stability capability. There are many balance exercises and strategies; to improve balance in elderly age group population, to prevent fall prevention. But we have very few evidences of giving manual perturbation balance training in stroke patients to improve speed, balance and function. Therefore this study is taken up to examine whether the manual perturbation balance training is more effective in improving speed, balance and function in 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 Jan 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

December 10, 2014

Last Update Submit

July 26, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

    patients ability of balance were assessed

    4 weeks

Secondary Outcomes (1)

  • Functional Independence Scale

    4 weeks

Other Outcomes (1)

  • Timed Up and Go Test

    4 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

manual perturbations were given in forward, Backward,right and left sideways, 10 perturbations were given,6 days in week,in fallowing positions- sitting,kneeling, standing positions

Other: PerturbationOther: Conventional Physiotherapy Treatment

Control group

PLACEBO COMPARATOR

Conventional Physiotherapy were given 6 days in a week, for 30 mins for 4 weeks, includes stretching, strengthening of contralateral limbs

Other: PerturbationOther: Conventional Physiotherapy Treatment

Interventions

PerturbationOTHER

Manual perturbations were given at waist region,over the Shoulders. in following positions- sitting, kneeling, standing positions,10 perturbations were given in forward,backward,both right and left side, 6 days in a week all precautionary measures taken for the patient's safety

Also known as: Manual Perturbation
Control groupExperimental Group
Conventional Physiotherapy TreatmentOTHER

Conventional Physiotherapy treatment were given to participants included in this group for 30 mins daily for 4 weeks

Also known as: control Group
Control groupExperimental Group

Eligibility Criteria

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

You may qualify if:

  • First ever stroke
  • Age ranges between 40-70
  • Both genders were included
  • Ambulatory patients with or without ambulatory aids
  • Occurrence of stroke at within 0-3 months i.e.-sub acute
  • Able to follow command
  • Mini mental scale examinations not less than 24

You may not qualify if:

  • Patients who has severe limitations in passive range of motion at lower extremities
  • Patients with impaired sensory, proprioceptor, cognitive and perceptual ability
  • Patient who has contracture
  • Orthopedic or any other neurological disorder which impair balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGM school Of Physiotherapy

Aurangabad, Maharashtra, 431003, India

Location

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Nawaj Pathan, PG student

    MGM School Of Physiotherapy,Aurangabad,Maharashtra, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.P.Th.PG student

Study Record Dates

First Submitted

December 10, 2014

First Posted

July 31, 2017

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 31, 2017

Record last verified: 2017-07

Locations

IN(1)