NCT01631604

Brief Summary

The purpose of this study is to quantify the safety degree of the patient's gait, to detect the reason for the fall and quantify the biomechanical parameters related to fall. This study also aims to evaluate the effect of different rehabilitation treatments and their effect on the risk of falling.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 27, 2017

Status Verified

June 1, 2012

Enrollment Period

5 years

First QC Date

June 28, 2012

Last Update Submit

April 26, 2017

Conditions

Keywords

risk of fallinggait patternsmuscle activityfall preventionmotor impairment

Outcome Measures

Primary Outcomes (1)

  • Gait kinematics

    Joint angles, velocities and accelerations

Secondary Outcomes (1)

  • Muscle activation patterns

Interventions

Walking aids, e.g. braces, canes,orthoses, prosthetics, etc.

Injection to muscle or nerve

Also known as: Botulinum toxin, Marcaine

correction of spinal and bony deformities, muscle transfer, tendon elongation etc.

Also known as: Knee arthroscopy, meniscectomy and chondroplasty, Anterior cruciate ligament reconstruction, Knee replacement, Repair of femoral neck fracture, Repair of trochanteric fracture, Debridement of skin/muscle/bone/fracture, Knee arthroscopy repair of both menisci, Hip replacement, Repair of ankle fracture (bimalleolar type), Lumbar spinal fusion, Low back intervertebral disc surgery, Repair of femoral shaft fracture

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals suffering from gait impairment following injury to the central or peripheral nervous system, as well as following orthopedic injuries. The subjects will be able to understand and independently sign a consent form.

You may not qualify if:

  • Subjects who are unable to understand and independently sign a consent form
  • Subjects who are wheelchair bound.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91240, Israel

Location

MeSH Terms

Interventions

Equipment and SuppliesBotulinum ToxinsBupivacaineMeniscectomyAnterior Cruciate Ligament ReconstructionArthroplasty, Replacement, KneeArthroplasty, Replacement, HipPhysical Therapy Modalities

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesOrthopedic ProceduresSurgical Procedures, OperativeArthroplastyPlastic Surgery ProceduresArthroplasty, ReplacementProsthesis ImplantationTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2012

First Posted

June 29, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

April 27, 2017

Record last verified: 2012-06

Locations