The Development and Clinical Verification of Intelligent Rehabilitation System for Leg Length Discrepancy Patients

NCT ID: NCT02793973

Last Updated: 2016-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Brief Summary

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A structural leg length discrepancy (SLLD) is a common clinical problem. Its prevalence has been estimated at 40-70%. Those who have been suffered from limping for a long time may lead to follow-up low back pain and lower limb musculoskeletal disorders. Although lower limb triple view of x-ray is considered to be the current technique for determining LLD, it is costly and time consuming that not every hospital can afford it, and in case of radiograph, the patient is exposed to radiation. Therefore, it is necessary to develop a rapid clinical assessment method by gathering exterior parameters to build up a Regression model for measuring the discrepancy and determining LLD accurately.

While using shoe lifts to correct discrepancy is the easiest conservative intervention for LLD, there are still many controversies on how much height should be added clinically and academically. The optimal height should be added depends on feedbacks from users and gait performance. The best gait performance can be measured from kinematic performance of center mass of body during walking. Therefore, this project wants to compare treatment responses between two kinds of shoe lift height correction methods for LLD: given 80% discrepancy in shoe lift height correction through triple view of x-ray and given optimal shoe lift height correction through analyzing kinematic performance of center mass of body.

Detailed Description

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Conditions

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Leg Length Discrepancy, Shoe Lifts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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80% discrepancy lift height correction

Each participant will be given 80% discrepancy shoe lift height correction through analyzing kinematic performance of center mass of body and will be required to wear the lifts in their shoes when they are walking or standing for 6 month.

Group Type ACTIVE_COMPARATOR

shoe lifts

Intervention Type DEVICE

optimal lift height correction

Each participant will be given the optimal shoe lift height correction through analyzing kinematic performance of center mass of body and will be required to wear the lifts in their shoes when they are walking or standing for 6 month.

Group Type EXPERIMENTAL

shoe lifts

Intervention Type DEVICE

Interventions

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shoe lifts

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* aged 20 to 70
* being able to walk independently
* being diagnosed with congenital SLLD or not
* willing to cooperate to wear shoe lifts
* has smart phone and willing to record information that investigators need
* willing to sign agreement

Exclusion Criteria

* neurological diseases (i.e. Parkinson's disease, CVA, Polio, and lower limb nerve injuries, etc.)
* diabetes along with peripheral neuropathy
* history of lower limb fracture injury or joint replacement leading to uneven leg length
* osteoporosis along with compression fracture
* foot, ankle, or knee joint deformity, osteoarthritis or soft tissue pain that disturb gait performance (ex. degenerative osteoarthritis, plantar fasciitis, and etc.)
* pregnancy
* idiopathic scoliosis
* history of psychological disease or drug addiction
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Si Huei Lee

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Central Contacts

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Chen Hsin Lu

Role: CONTACT

886+2+28712121 ext. 2931

References

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DENSLOW JS, CHACE JA. Mechanical stresses in the human lumbar spine and pelvis. J Am Osteopath Assoc. 1962 May;61:705-12. No abstract available.

Reference Type BACKGROUND
PMID: 13885486 (View on PubMed)

NELSON CR. Postural analysis and its relation to systemic disease. J Am Osteopath Assoc. 1948 Jul;47(11):555-8. No abstract available.

Reference Type BACKGROUND
PMID: 18872347 (View on PubMed)

Greenman PE. Lift therapy: use and abuse. J Am Osteopath Assoc. 1979 Dec;79(4):238-50. No abstract available.

Reference Type BACKGROUND
PMID: 159883 (View on PubMed)

Hoffman KS, Hoffman LL. Effects of adding sacral base leveling to osteopathic manipulative treatment of back pain: a pilot study. J Am Osteopath Assoc. 1994 Mar;94(3):217-20, 223-6.

Reference Type BACKGROUND
PMID: 8200825 (View on PubMed)

Baylis WJ, Rzonca EC. Functional and structural limb length discrepancies: evaluation and treatment. Clin Podiatr Med Surg. 1988 Jul;5(3):509-20.

Reference Type BACKGROUND
PMID: 3293752 (View on PubMed)

Blake RL, Ferguson HJ. Correlation between limb length discrepancy and asymmetrical rearfoot position. J Am Podiatr Med Assoc. 1993 Nov;83(11):625-33. doi: 10.7547/87507315-83-11-625.

Reference Type BACKGROUND
PMID: 8258774 (View on PubMed)

Bhave A, Paley D, Herzenberg JE. Improvement in gait parameters after lengthening for the treatment of limb-length discrepancy. J Bone Joint Surg Am. 1999 Apr;81(4):529-34. doi: 10.2106/00004623-199904000-00010.

Reference Type BACKGROUND
PMID: 10225798 (View on PubMed)

D'Amico JC, Dinowitz HD, Polchaninoff M. Limb length discrepancy. An electrodynographic analysis. J Am Podiatr Med Assoc. 1985 Dec;75(12):639-43. doi: 10.7547/87507315-75-12-639. No abstract available.

Reference Type BACKGROUND
PMID: 4078719 (View on PubMed)

Related Links

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Other Identifiers

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2016-01-011A

Identifier Type: -

Identifier Source: org_study_id

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