UMIN-ICDS Clinical Trial

Public title

Effects of Stepping Exercise Using the Non-paralyzed Leg on Muscle Oxygen Levels in the Paralyzed Leg of Stroke Patients

Acronym

SmO2-STEP Study

Scientific Title

Effect of Non-paretic Lower Limb Stepping Exercise on Muscle Oxygen Saturation of the Paretic Gastrocnemius and Tibialis Anterior Muscles in Patients with Acute Stroke

Scientific Title:Acronym

SmO2-STEP Study

Region

Japan

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To measure muscle oxygen saturation (SmO2) of the paretic gastrocnemius (lateral head) and tibialis anterior muscles during non-paretic leg stepping exercise in patients with acute stroke, and to clarify the effect of dynamic paretic-side loading on SmO2 as well as the feasibility of this protocol.

Basic objectives2

Others

Basic objectives -Others

As this protocol has no prior precedent, this study is positioned as a preliminary feasibility study to confirm feasibility (recruitment and consent status, dropout rate, intervention adherence rate, measurement completion rate, and safety) prior to a full-scale efficacy trial.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

Muscle oxygen saturation (SmO2) of the paretic gastrocnemius (lateral head) and tibialis anterior muscles, measured by near-infrared spectroscopy (NIRS) using the MOXY device (resting SmO2, minimum SmO2, delta SmO2, recovery slope, t1/2 recovery time).

Key secondary outcomes

(1) Physical function assessments (level of consciousness, motor paralysis, pusher phenomenon, walking ability) and subjective fatigue (Borg Scale). (2) Feasibility outcomes (recruitment and consent status, dropout rate, intervention adherence rate, measurement completion rate, and safety).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Non-paretic leg stepping exercise. Patients perform stepping exercise with the non-paretic leg while wearing a long leg orthosis and holding onto parallel bars (3 sets of 30 seconds, over 5 weekdays).

Interventions/Control_2

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

60

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) First-ever cerebral infarction or hemorrhage, aged 60-85 years; (2) Functional Ambulation Categories (FAC) 2 or less (with long leg orthosis) and lower-limb Brunnstrom Stage IV or less at initial assessment; (3) Able to maintain standing with parallel bar support under close supervision while wearing a long leg orthosis; (4) Good comprehension of instructions.

Key exclusion criteria

(1) Difficulty with independent walking (FAC 3 or less) before onset; (2) Orthopedic conditions such as fractures, or severe contracture; (3) Pusher phenomenon (Scale for Contraversive Pushing 1 or more); (4) Bilateral lesions; (5) Parkinsonism; (6) Cerebellar disease; (7) Unstable general condition (severe disturbance of consciousness, anemia, deep vein thrombosis, oxygen therapy, or vital sign changes requiring urgent medical attention persisting for 2 days); (8) Patients already flagged by a physician or nurse for skin injury risk prior to physical therapy intervention.

Target sample size

20

Name of lead principal investigator

1st name	Yuto
Middle name
Last name	Tachikawa

Organization

Tokyo Saiseikai Central Hospital

Division name

Department of Rehabilitation

Zip code

1080073

Address

1-4-17 Mita, Minato-ku, Tokyo, Japan

TEL

03-3451-8211

Email

26895711@ed.tmu.ac.jp

Name of contact person

1st name	Yuto
Middle name
Last name	Tachikawa

Organization

Tokyo Saiseikai Central Hospital

Division name

Department of Rehabilitation

Zip code

1080073

Address

1-4-17 Mita, Minato-ku, Tokyo, Japan

TEL

03-3451-8211

Homepage URL

Email

26895711@ed.tmu.ac.jp

Institute

Tokyo Saiseikai Central Hospital

Institute

Department

Personal name

Organization

Tokyo Saiseikai Central Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Research Center, Tokyo Saiseikai Central Hospital

Address

1-4-17 Mita, Minato-ku, Tokyo, Japan

Tel

03-3451-8211

Email

kenkyu@saichu.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京都済生会中央病院(東京都)

Date of disclosure of the study information

2026

Year

10

Month

16

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

10

Month

16

Day

Date of IRB

Anticipated trial start date

2027

Year

01

Month

12

Day

Last follow-up date

2028

Year

01

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

10

Month

16

Day

Last modified on

2026

Year

10

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072470