UMIN-CTR Clinical Trial

Public title

Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients

Acronym

Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients

Scientific Title

Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients

Scientific Title:Acronym

Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients

Region

Japan

Condition

stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study was to test whether the recovery of upper limb function in stroke patients would be enhanced by additionally carrying training aimed at improving sensory function.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Brunnstrom stage
Handgrip strength
Tactile-pressure threshold
Simple test for evaluating hand function (STEF)

Key secondary outcomes

Changes in handgrip strength, tactile pressure threshold, and STEF

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

Intervention group
<Rehabilitation program>
1.ROM (Range of motion) training
2.facilitation (voluntary promotion training)
3.Muscle-strengthening exercise
4.Mobility skill exercises such as transferring, sitting up and Walking exercises
5.Standard of Exercises for ADL
6.Higher brain dysfunction training
<Sensory training program>
Several types of discrimination task performed under blind condition.
1.Three types of sandpaper, cloth (fur, satin fabric, linen cloth), 3 types of materials (0.5mm sponge cushioning materials, bubble wrap, flat plastic plate)
2.Braille plate

Interventions/Control_2

Control group
<Rehabilitation program>
1.ROM (Range of motion) training
2.facilitation (voluntary promotion training)
3.Muscle-strengthening exercise
4.Mobility skill exercises such as transferring, sitting up and Walking exercises
5.Standard of Exercises for ADL
6.Higher brain dysfunction training

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Medically stable
Had no peripheral neuropathy or history of other neurological conditions
Had adequate comprehension of instructions and perceptual ability for testing
All were assessed to be free of unilateral neglect using clinical observation and standard neuropsychological assessment (shape cancellation and line bisection)
The Mini-Mental State Examination, which all of them passed (border line passing score of 24)

Key exclusion criteria

Any participants that does not meet the conditions specified in the above shall be null and void

Target sample size

50

Name of lead principal investigator

1st name	Jun
Middle name
Last name	Murata

Organization

Nagasaki University

Division name

Graduate School of Biomedical Sciences

Zip code

852-8520

Address

1-7-1 Sakamoto, Nagasaki 852-8520, Japan

TEL

095-819-7923

Email

jmura@nagasaki-u.ac.jp

Name of contact person

1st name	Jun
Middle name
Last name	Murata

Organization

Nagasaki University

Division name

Graduate School of Biomedical Sciences

Zip code

852-8520

Address

1-7-1 Sakamoto, Nagasaki 852-8520, Japan

TEL

095-819-7923

Homepage URL

Email

jmura@nagasaki-u.ac.jp

Institute

Nagasaki University

Institute

Department

Personal name

Organization

Ministry of Education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Graduate School of Biomedical Sciences, Nagasaki University

Address

1-7-1 Sakamoto, Nagasaki, Japan

Tel

095-819-7923

Email

jmura@nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立病院機構長崎医療センター/National Hospital Organization
Nagasaki Medical center

Date of disclosure of the study information

2018

Year

04

Month

01

Day

URL releasing protocol

https://doi.org/10.1155/2019/6508261

Publication of results

Published

URL related to results and publications

https://doi.org/10.1155/2019/6508261

Number of participants that the trial has enrolled

56

Results

The mean change in the tactile pressure threshold was significantly larger in the experimental group than in the control group (p<0.05, d=0.59). Moreover, the completion times to manipulate a middle-sized ball (d=0.53) and small ball (d=0.80) and a small metal disc (d=0.81) in the experimental group were significantly different from those in the control group (p<0.05).

Results date posted

2024

Year

03

Month

14

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Subjects were hospitalized and receiving therapeutic interventions at the rehabilitation unit. The following inclusion criteria were used:first time stroke; the Revised Hasegawa Dementia Scale (HDS-R) score higher than 21; no severe cognitive deficits that preclude clinical evaluations, such as aphasia and unilateral neglect; and no other serious medical conditions.

Participant flow

A quasi-randomized 2-group pretest-posttest was used to examine the effects of the sensory training program in addition to standard rehabilitation therapy on paralyzed upper limbs. During the research period between July 2015 and January 2016, thirty-one subjects participated in the experimental group that performed the sensory training program in addition to standard rehabilitation therapy. After the end of this research period, an additional 25 patients were enrolled during the research period between February 2016 and August 2017 as the control group that received standard rehabilitation therapy without the sensory training program.

Adverse events

none

Outcome measures

The mean change in the tactile pressure threshold was significantly larger in the experimental group than in the control group (p<0.05, d=0.59). Moreover, the completion times to manipulate a middle-sized ball (d=0.53) and small ball (d=0.80) and a small metal disc (d=0.81) in the experimental group were significantly different from those in the control group (p<0.05).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

06

Month

01

Day

Date of IRB

2014

Year

08

Month

04

Day

Anticipated trial start date

2015

Year

08

Month

01

Day

Last follow-up date

2019

Year

11

Month

04

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

03

Month

30

Day

Last modified on

2024

Year

03

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036544