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Lower Limb and Walking

Hip-Knee-Ankle-Foot Orthosis in SCI

Author Year; Country
Score
Research Design
Sample Size		 Methods Outcomes

Arazpour et al. 2013; Iran
PEDro=4
RCT
Level 2
N=5

 Population: 5 participants with T8-T12 SCI (4M, 1F); had ability to walk with an ARGO for a minimum of 50m independently; completed a 12-wk gait training rehab program.
Treatment: Patients were randomized to either an ARGO with solid or dorsiflexion-assist type AFO. They walked at their self-selected speed along a flat walkway.
Outcome Measures: Walking speed, distance walked, cadence, MFES.
  1. Mean MFES score when using the ARGO with solid AFOs (45.8 (9.12)) was significantly higher than when using the dorsiflexion-assisted AFOs (42.8(9.73)).
  2. During static dual-elbow crutch support, there was no significant different between the two types of orthosis in the postural sway in medio-lateral direction, but significant difference between them in the antero-posterior direction. During single crutch support, there was a significant difference in both medio-lateral and antero-posterior directions.
  3. Walking speed (7%) and endurance (5%) significantly increased when using the ARGO with dorsiflexion-assisted AFOs compared with solid AFO.

Bani et al. 2013; Iran
Pre-post
Level 4
N=4

 Population: 4 participants with SCI (3M 1F); 24-29 yrs old; 12-36 months post-injury; 1 AIS A, 3 AIS B.
Treatment: Patients completed at least 6 weeks of orthotic gait training using an ARGO with 2 types of AFO. Patients then walked with the orthoses along a 6-m walkway at least 5 times at self-selected walking speed in 2 test conditions: 1) ARGO with dorsiflexion-assisted AFO, 2) ARGO with solid AFO.
Outcome Measure: Walking speed, endurance, cadence, stride length, kinematic and spatio-temporal parameters of walking.
  1. Mean walking speed (solid AFO=0.32(0.02); dorsi AFO=0.35(0.01) m/s), cadence (solid AFO=40(2.38), dorsi AFO=42(3.09) steps/min) and stride (solid AFO=94.5(9.25), dorsi AFO=100(9.48) cm) significantly increased for participants using the ARGO fitted with dorsiflexion AFO compared to ARGO fitted with solid AFO.
  2. Mean ankle joint ranges of motion were significantly increased when walking with the ARGO with dorsiflexion-assisted AFO (11.63(0.75)o) compared to ARGO with solid AFO (8.05(0.51)o). Knee joint ranges of motion were reduced and hip joint ranges of motion were increased, but not significantly.

Nakazawa et al. 2004; Japan
Pre-post
Level 4
N=3

 Population: 3 males; age 22-28 years; all participants had a diagnosis of AIS A; T8 -T12 lesion level; 8-12 months post-injury.
Treatment: WBCO: 1 hr, 5x/wk, 12 wks.
Outcome measures: Gait velocity.
  1. All participants showed an increase in gait velocity: 7.7 to 13.2; 11.8 to 21.2, 22.4 to 25m/min.

Samadian et al. 2015; Iran
Pre-Post
Level 4
N= 6

 Population: 6 individuals- 4 males and 2 females; motor complete SCI ranging from T8 to T12; 2 AIS A and 4 AIS B; mean age= 29y; months post injury= 7 to 35 months.
Treatment: Patients were trained for 12 weeks of gait training after construction of the orthosis that comprised of five sessions per week for a 2-h period with the orthosis. The gait training program also included passive stretching of the lower extremities, upper limb strengthening and balance training with the orthosis while standing and walking. Gait evaluation was performed at baseline and after 4, 8 and 12 weeks. Walking speed and heart rate were measured to calculate the resulting physiological cost index (PCI).
Outcome Measures: Walking speed, distance walked, energy consumption, physiological cost index (PCI).
  1. Walking distance increased significantly and also did so during the 8–12-week period.

Scivoletto et al. 2000; Italy
Post-test
Level 4
N=24

 Population: 24 males and females; mean (SD) age 33.6(3.2) yrs; AIS A; T1-T12 lesion level; mean (SD) 5.3 (2.1) yrs post-injury.
Treatment: RGO: training, then home-use for 1 year.
Outcome measures: gait speed, going up and down stairs, use of walker or crutches, Garrett Score (out of 6; 6 = community ambulation with no limitations; 1=hospital ambulation).
  1. No difference between RGO users and RGO nonusers for gait speed, stair climbing, or ambulatory aid. However, RGO users achieved home ambulation with limitations or home ambulation (level 2-3), while nonusers achieved hospital ambulation or home ambulation with limitations (level 1-2). No one reached community ambulation levels.

Massucci et al. 1998; Italy
Post-test
Level 4
N=6

 Population: 6 males; age 16-31 yrs; all participants had a diagnosis of Frankel A; T3-T12 lesion level; 12-51 months post-injury.
Treatment: Rehabilitation training with advanced RGO for 6-8 weeks (including muscle strengthening, standing balance, gait training, stair climbing).
Outcome measures: Walking speed over 5 m.
  1. Participants achieved walking speeds of between 7.8 and 16 m/min with the orthosis.

Franceschini et al. 1997; Italy
Post-test
Level 4
N=74

 Population: 74 males and females; mean age 27 yrs; all participants had a diagnosis of Frankel A or B; T1-T12 lesion level; mean 37 yrs post-injury.
Treatment: Orthoses: RGO (n=53), Advanced RGO (RGO with links between mechanical hip joints and hip and knee joints) (n=17), and HGO (n=4). Practice to don/doff device and functional mobility. Follow-up at hospital discharge and 6 months later.
Outcome measures: Garrett Score, ability to climb up and down 12 steps.
  1. At discharge, 28 patients could climb stairs (13 with crutches, 15 with a walker).
  2. The ability to climb stairs or Garret score at discharge was associated with continued orthosis use. 31 patients achieved functional gait (Garrett = 2-5) and 9 achieved community ambulation (Garrett=4-5). 19 used orthosis only for exercise (Garrett=1).

Harvey et al. 1997; Australia
Post-test
Level 4
N=10

 Population: 10 participants; mean (SD) age 37(8.4) yrs; all participants had a motor complete SCI; T9-T12 lesion level; 4-19 yrs post-injury.
Treatment: WO[1] vs. IRGO[2]: training with first orthosis 2-3 hours, 2-3X/week for 6-8 weeks, followed by 3-month home trial period. 2-month wash-out period (no orthosis) followed by other orthosis.
Outcome measures: functional skills (e.g., curbs, stairs, donning/doffing, sit-stand), Functional Independence Measure, gait speed over flat and inclined surfaces.
  1. No differences between orthoses re: donning/doffing (“independent”), stairs and curbs (“stand-by” or “minimal”), or level gait (“independent” or “stand-by”).
  2. Tendency for better performance with IRGO for flat walking, ramp walking, and stairs. Faster gait with IRGO on flat (mean (SD) IRGO=0.34 (0.18) m/s, mean (SD) WO=0.14 (0.12) m/s) and on inclined surfaces. IRGO allowed more independent gait; WO easier to go from sit-stand and stand-sit.
  3. Neither orthosis enabled participants to be fully independent in the key skills necessary for functional ambulation after 8 weeks of training.

Saitoh et al. 1996; Japan
Pre-post
Level 4
N=5

 Population: 5 males; age 26-36 yrs; 4 participants had a diagnosis of Frankel A and 1 participant had a diagnosis of Frankel C; T5-L1 lesion level; 8.4-70 mos post-injury.
Treatment: MSH-KAFO: Long-leg hip-knee-ankle-foot brace with medially-placed single-axis hip joint. Patients were trained to stand and walk using device daily for 2 wks, followed by an exercise program 1-2x/wk.
Outcome measures: walking speed and distance.
  1. 4 of 5 were able to stand without crutches with MSH-KAFO (1 participant needed parallel bars).
  2. 3/5 could climb stairs with crutches and rail.
  3. After 3-10 months of therapy, gait speed improved from 0.05-0.2 m/s to 0.17-0.63 m/s and walking distance ranged from 300 to 4000 m.

Lotta et al. 1994; Italy
Post-test
Level 4
N=28

 Population: 24 males and 4 females; age 15-48 yrs; all participants had a diagnosis of Frankel A or B; T3-T12 lesion level; 8-312 wks post-injury.
Treatment: 3.5-6 sessions/week, 3-16 weeks of training with advanced reciprocating gait orthosis (hip-knee-ankle orthosis).
Outcome Measures: Garrett Scale for ambulation.
  1. All patients able to walk at least 30 m with walker or forearm crutches.
  2. 3 participants attained “community” ambulation levels; 17 attained “home” level; 8 remained as “exercise only” ambulation level.
  3. Median gait speed with orthosis was 16.6 cm/s.

Winchester et al. 1993; USA
Post-test
Level 4
N=4

 Population: 4 males; age 24-36 yrs; 2 participants with complete SCI and 2 participants with motor-incomplete SCI; T5-T10 lesion level; 25-58 months post-injury.
Treatment: Gait training with RGO or IRGO: 2 hrs, 2-3x/wk (average total time = 35 ± 7.5 hr).
Outcome measures: Gait velocity, cadence.
  1. Overall, participants achieved overground velocity of mean (SD) 12.7 (1.9) m/min with RGO and 13.5 (2.1) m/min with IRGO; cadence of 30.3 (6.2) steps/min with RGO and 31.3 (7.9) steps/min with IRGO.

Whittle et al. 1991; UK
Post-test
Level 4
N=22

 Population: 22 males and females; age 21-44 yrs; all participants had a SCI diagnosis; T3-T12 lesion level.
Treatment: HGO (aka Parawalker) + crutches vs. RGO + rollator walker: Practice period + 4-month home use before being switched to the second orthosis.
Outcome measures: walking speed, cadence, and stride length.
  1. No significant differences between orthoses for gait speed, cadence, and stride length.
  2. Mean walking speed with either orthosis was 0.24 m/s.
  3. RGO enabled faster sit-to-stand and stepping up on curbs.
[1] Similar model to the MSH-KAFO
[2] Successor model to the RGO (uses a central pivot bar and tie rod arrangement instead of crossed-cable to couple hip flexion/extension). The IRGO is thought to be less fatiguing for participants compared to RGO (Winchester et al 1993).

Discussion

The Reciprocating Gait Orthosis (RGO) (or variants of it) is the most common bilateral HKAFO for people with thoracic injuries. In most cases, experimental conditions involving activities without an RGO would not be possible for the participant, and thus, the RGO permits ambulation and in some cases, stairs to be performed.

None of the studies investigating the effectiveness of the braces for upright support and mobility are randomized using a control group without any brace/device, but that is in part due to the ethical dilemma of providing safe and appropriate bracing, and in many cases, participants would not be able to walk safely without the brace. Several studies compare two or more different types of devices, and in some cases (e.g. Arazpour et al. 2013b), the conditions were randomized during the testing. Some of the studies did provide a substantial training period (e.g., 5 times/week gait training sessions with braces for at least 2 weeks). Overall, these studies provided level 4 evidence that HKAFOs may help people with subacute or chronic complete paraplegia to stand independently and to achieve some functional ambulation skills, such as stepping up on curbs or climbing stairs with assistive devices. The maximum walking speeds achieved with orthosis use ranged from 0.13 to 0.63 m/s (Nakazawa et al. 2004; Massucci et al. 1998; Harvey et al. 1997; Saitoh et al. 1996; Sykes et al. 1996b; Thoumie et al. 1995; Winchester et al. 1993; Whittle et al. 1991), which is 13 to 57% of the optimal speed (1.1 m/s) required for successful community ambulation (Robinett and Vondran 1988). In general, however, the use of any of the braces investigated in these studies did not greatly enhance the ability of complete paraplegic subjects to be fully independent for functional community ambulation (Scivoletto et al. 2000; Harvey et al. 1997; Hong et al. 1990). In a few studies, some subjects demonstrated the ability to climb up and down stairs with the assistance of crutches or walkers (Franceschini et al. 1997; Harvey et al. 1997; Whittle et al. 1991). Thus, the greatest benefit derived from orthosis/brace use is from enhanced home or indoor mobility, general exercise and health benefits, and psychological benefits from attaining upright posture and standing (Sykes et al. 1996b; Hong et al. 1990; Mikelberg and Reid 1981).

The successful use of orthoses/braces is also dependent on other more individual and practical factors. It has been recommended that orthoses or braces are best for people who are well-motivated, with complete SCI at T9 or below or incomplete SCI at any level, with good postural control and a good level of fitness (Franceschini et al. 1997; Thoumie et al. 1995; Hong et al. 1990). Suzuki et al. (2007) showed that injury level, age, motivation, upper extremity strength, as well as spasticity and contractures were predictive of gait outcomes in long-leg brace users. Medical problems such as limited thoracolumbar mobility or mechanical back pain, or any musculoskeletal problems that make standing upright uncomfortable also tend to interfere with successful use of these orthoses/braces (Harvey et al. 1997; Middleton et al. 1997).

The ability for a patient to don/doff the orthosis without difficulty and relatively quickly (e.g. <5 minutes) also appears to enhance the probability of their acceptance (Scivoletto et al. 2000; Franceschini et al. 1997; Harvey et al. 1997; Saitoh et al. 1996; Thoumie et al. 1995; Hong et al. 1990; Mikelberg and Reid 1981). Frequent reports of technical problems (e.g. mechanical breakdown at the hinges, improper fitting) across many studies (Scivoletto et al. 2000; Harvey et al. 1997; Thoumie et al. 1995; Whittle et al. 1991; Mikelberg and Reid 1981) suggest that appropriate technical support of these mechanical devices is necessary to enhance ongoing use of these braces (Whittle et al. 1991).

Overall, it appears that most subjects feel that the difficulties and inconvenience encountered with orthoses/braces and the modest increase in function do not warrant their acceptance for regular, daily use in functional activities (Harvey et al. 1997; Sykes et al. 1996b; Hong et al. 1990; Mikelberg and Reid 1981). It has been suggested that the therapeutic benefits of orthosis-use (e.g. health benefits from standing practice) should be stressed to patients rather than setting forth an expectation that they will enhance functional ambulation and be a replacement for wheelchair-use (Franceschini et al. 1997).

Conclusion

There is level 4 evidence (see Table 11) that a reciprocating gait orthosis can enable walking in people with thoracic lesions, although not at speeds sufficient for community ambulation.

RGO can enable slow walking in participants with thoracic lesions, and not at speeds sufficient for community ambulation.

The advantages of RGOs appear largely restricted to the general health, well-being, and safety benefits related to the practice of standing and the ability to ambulate short distances in the home or indoor settings.

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