UMIN-ICDS Clinical Trial

Public title

Effect of gait training using a leg brace with therapist support from behind in people with stroke who are unable to walk independently.

Acronym

Effect of assisted gait training using a leg brace in people with stroke.

Scientific Title

Effects of Alternate Gait Training Using a Knee-Ankle-Foot Orthosis in Non-Ambulatory Patients With Stroke : A Non-Randomized Controlled Trial

Scientific Title:Acronym

Effects of Alternate Gait Training Using a Knee-Ankle-Foot Orthosis in Non-Ambulatory Patients With Stroke

Region

Japan

Condition

stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The use of a knee-ankle-foot orthosis (KAFO) is recommended for patients with post-stroke hemiparesis who have insufficient knee extensor or hip muscle function. However, no standardized method of providing assistance during gait training with a KAFO has been established. Recently, Alternate Gait Training (AGT), a gait training method using a knee-ankle-foot orthosis with the oil damper ankle hinge, in which a physical therapist provides manual assistance from behind to facilitate alternating large hip flexion and extension movements during walking, has been proposed. AGT has been reported to enhance muscle activity in the paretic lower limb and produce muscle activation patterns during gait that more closely resemble those of healthy individuals. However, it remains unclear whether long-term AGT improves walking function.
Therefore, the purpose of this study was to compare the long-term effects of AGT and conventional KAFO gait training on walking independence, gait pattern, and lower-limb joint kinematics in non-ambulatory patients with stroke undergoing inpatient rehabilitation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The number of days required to achieve walking without knee buckling while using an ankle-foot orthosis (AFO) in the parallel bars, and the number of days required to achieve Functional Ambulation Category (FAC) level 2 while walking with an AFO and a cane or crutch.

Key secondary outcomes

Gait pattern, gait speed, and trailing limb angle (TLA) at the time participants achieved walking without knee buckling in the parallel bars while wearing an ankle-foot orthosis (AFO), and at the time they reached Functional Ambulation Category (FAC) level 2 while walking with an AFO and a cane or crutch.

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Participants undergo Alternate Gait Training (AGT) using a knee-ankle-foot orthosis with the oil damper ankle hinge for at least 20 minutes per day, at least 5 days per week. Preparation and rest periods are not included in the training time. The intervention is delivered by physical therapists with at least 3 years of clinical experience who have received prior training in the principles and techniques of AGT. During AGT, the therapist maintains close contact with the participant from behind, assists trunk alignment in a neutral to forward-leaning posture throughout the gait cycle, facilitates hip extension of the paretic limb during terminal stance, and facilitates weight transfer to the non-paretic limb during the swing phase of the paretic limb. The intervention period is up to 6 weeks from the initiation of the intervention. If participants transition from a knee-ankle-foot orthosis (KAFO) to an ankle-foot orthosis (AFO) or another type of orthosis during the intervention period, the study intervention using the KAFO is discontinued at the time of transition.

Interventions/Control_2

Participants undergo gait training using a knee-ankle-foot orthosis (KAFO) for at least 20 minutes per day, 5 days per week, with as little physical assistance as possible to encourage active participation. Preparation and rest periods are not included in the training time. The intervention period is a maximum of 6 weeks from the start of the intervention. If the KAFO is replaced with an ankle-foot orthosis (AFO) or another type of orthosis during the intervention period, the study intervention using the KAFO is discontinued at the time of replacement.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) a Brunnstrom Recovery Stage (BRS) of IV or lower for the affected lower extremity
(2) first-ever stroke
(3) a Functional Ambulation Category (FAC) score of <= 1 at hospital admission
(4) demonstrated knee buckling during walking with an ankle-foot orthosis (AFO) at hospital admission

Key exclusion criteria

(1) requiring assistance for indoor ambulation before stroke onset
(2) the presence of orthopedic disorders affecting walking ability
(3) cognitive impairment or higher brain dysfunction that interfered with gait assessment or training
(4) severe impaired consciousness (Japan Coma Scale [JCS] >= II)
(5) bilateral motor paralysis

Target sample size

60

Name of lead principal investigator

1st name	Takeshi
Middle name
Last name	Mizuguchi

Organization

Ukai Rehabilitation Hospital, Keizankai Medical Corporation

Division name

Department of Rehabilitation

Zip code

453-0811

Address

4-1 Taiko-dori, Nakamura-ku, Nagoya, Aichi, Japan

TEL

052-461-3132

Email

mizuguchit83@gmail.com

Name of contact person

1st name	Takeshi
Middle name
Last name	Mizuguchi

Organization

Ukai Rehabilitation Hospital, Keizankai Medical Corporation

Division name

Department of Rehabilitation

Zip code

453-0811

Address

4-1 Taiko-dori, Nakamura-ku, Nagoya, Aichi, Japan

TEL

052-461-3132

Homepage URL

Email

mizuguchit83@gmail.com

Institute

Ukai Rehabilitation Hospital, Keizankai Medical Corporation

Institute

Department

Personal name

Yoshiaki Maki

Organization

Japanese Society for Prosthetics and Orthotics

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ukai Rehabilitation Hospital, Keizankai Medical Corporation

Address

4-1 Taiko-dori, Nakamura-ku, Nagoya, Aichi, Japan

Tel

052- 461-3132

Email

mizuguchit83@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

08

Month

01

Day

Last follow-up date

2028

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

07

Month

31

Day

Last modified on

2026

Year

07

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071323