Innovative development of gait assistant device for adult scoliosis

JRCT ID: jRCTs042210131

Registered date:19/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult Spinal Deformity (ASD)
• Date of first enrollment: 17/10/2022
• Target sample size: 28
• Study type: Interventional
• Intervention(s): Electromyogram synchronized gait analysis with or without ACSIVE at preoperative and postoperative 1 month and 1 year

Outcome(s)

Primary Outcome

A comparison gait speed(m/s) between with and without ACSIVE due to gait analysis
preoperatively.

Secondary Outcome

(1) A comparison gait speed between with and without ACSIVE due to gait analysis
postoperative 1 month and 1 year.
(2) some gait parameters by VICON
walking rate per 1 gait cycle
step
length of stride
swing phase
double supporting phase
Max and Min. ROM of pelvis and lower extremity
(3) some parameters of EMG
50 percentage muscle activity
percentage maximum voluntary contraction
integrated Electromyogram of some muscles
(back cervical muscle, back muscle, lumbar muscle, abdominal muscle, rectus femoris muscle, biceps femoris muscle, tibialis anterior muscle, gastrocnemius muscle)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients met all criteria as below
(1) have an adult spinal deformity plannning operation in gifu university hospital
(2) adult
(3) good communication
(4) written consent has been obtained

Exclude criteria

(1) superimposed adolescent idiopathic scoliosis
(2) neuromuscular scoliosis
(3) syndromic scoliosis
(4) difficulty in stable walking due to severe spinal imbalance
(5) during pregnancy or lactation, potential or willingness
(6) postoperative progression of spinal deformity in proximal or distal junction
(7) using gait assistant device such as a cane to compensate for decline of ADL
(8) patients considered ineligible for enrolling the study by a principal investigator or sub-investigator

Related Information

• Primary Sponsor: Iwai Chizuo
• Secondary Sponsor: Akiyama Haruhiko
• Source(s) of Monetary Support: Grant in Aid for Scientific Research, Grant in Aid for Scientific Research(C)